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NIA-Funded Active Alzheimer’s and Related Dementias Clinical Trials and Studies

The National Institute on Aging (NIA) is currently supporting 488 active clinical trials on Alzheimer’s disease and related dementias (AD/ADRD). These trials reflect diverse drug and mechanistic targets, as well as diversity in the stages of AD/ADRD they address. NIA’s active trials include: Clinical Drug Development – Phase I and II (59), Clinical Drug Development – Phase II/III and Phase III (14), Non-drug (171), Dementia Care and Caregiving (213), Diagnostic Tools, Assessment, & Imaging Studies (23), and Treatments for Neuropsychiatric Symptoms (8). Please see the tables below for more details about these trials.*

Bar graph of NIA-Funded Alzheimer's and related dementia research in various categories
Bar graph of NIA-Funded Alzheimer's and related dementia research in various categories

Please note: The data in the graphics are from September 2023.

On this page:

*The data in the tables below are from September 2023

Section 1: Clinical Drug Development – Phase I and II

Amyloid
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Clinical Trials to Prevent Alzheimer's Disease in Down Syndrome Trial-Ready Cohort-Down Syndrome (TRC-DS) (TRC-DS) Michael S. Rafii, University of Southern California Anti-Aβ immunotherapy to remove amyloid plaques Non-demented adults with down syndrome (Ages 35 - 55) 2025
A Single Ascending Dose, Multiple Ascending Dose Phase I Study of the GSM 776890 in Healthy Normal Subjects TBD Douglas Galasko, University of California San Diego Gamma secretase modulator (GSM)776890, an Allosteric modulator of amyloid precursor protein (APP) processing, to attenuate Alzheimer's disease pathology Healthy adult participants 2025
A Seamless Phase 2A-B Randomized Double Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of PQ 912 in Patients with Early Alzheimer's Disease A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD (VIVA-MIND) Howard Feldman, University of California San Diego PQ 912, a small molecule glutaminyl cyclase (QC) inhibitor to treat both amyloidopathy and neuroinflammation Adults with mild cognitive impairment or mild probable Alzheimer's disease (Ages 50 - 89) 2024
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies (COG1201) Anthony Caggiano, Cognition Therapeutics Inc CT1812, a small molecule sigma2 receptor antagonist that displaces Aß oligomers bound to neuronal receptors at synapses Individuals with mild to moderate Lewy Body Dementia 2024
A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimer's Disease Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer’s Disease Using EEG Anthony Caggiano, Cognition Therapeutics, Inc. CT1812, a small molecule sigma2 receptor antagonist that displaces Aß oligomers bound to neuronal receptors at synapses Adults with mild to moderate Alzheimer's disease (Ages 50 - 80) 2023
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Mild to Moderate Alzheimer's Disease A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease Anthony Caggiano, Cognition Therapeutics, Inc. CT1812, a small molecule sigma2 receptor antagonist that displaces Aß oligomers bound to neuronal receptors at synapses Adults with Mild to Moderate Alzheimer's Disease (Ages 50 - 85) 2024
Safety/Tolerability/Immunogenicity of First-in-Human Aβ DNA Vaccine, AV-1959D Phase 1 Trials in Early-Stage AD Subjects: Based on IND18953 Cleared by FDA Study of AV-1959, an Amyloid Beta Vaccine Michael Agadjanyan, Institute For Molecular Medicine AV-1959D, a DNA based vaccine targeting amyloid beta to reduce amyloid plaque Early Alzheimer's disease participants (Ages 60 - 85 2027
Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease over 18 Months A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Anthony Caggiano, Cognition Therapeutics, Inc. CT1812, a small molecule sigma2 receptor antagonist that displaces Aß oligomers bound to neuronal receptors at synapses Older adults with early Alzheimer's disease, late mild cognitive impairment, and mild Alzheimer's disease dementia 2027
Circadian Rhythm
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Evaluating the Disease-Modifying Potential of a Sleep Intervention for Alzheimer's Disease Outcomes Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging Natalie Denburg, University of Iowa Melatonin, a hormone that regulates sleep, to improve cognition in older adults Older adults (Ages 60 - 75) 2024
Improving Sleep and AD Biomarkers: A Pilot RCT of Citicoline TBD Victoria Pak, Emory University Examine whether Citicoline (a dietary choline supplement) can significantly increase choline levels and decrease inflammatory and potentially Alzheimer's disease (AD)-associated biomarkers during a prodromal stage of AD (mild cognitive impairment due to AD) Mild cognitive impairment (Ages 60+) 2025
Effect of Suvorexant on Alzheimer's Disease Biomarkers TBD Brendan Lucey, Washington University in St. Louis Suvorexant, a dual orexin receptor antagonist (DORA), to decrease cerebrospinal fluid tau and phosphorylated tau and to prevent Alzheimer's disease Cognitively healthy, amyloid-positive people with symptomatic insomnia (Ages 65+) 2028
Growth Factors and Hormones
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Clinical Trial of AAV2-BDNF Gene Therapy in Alzheimer's Disease A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment Mark Tuszynski, University of California San Diego Brain Derived Neurotrophic Factor (BDNF) Gene Therapy to potentially slow or even reverse cognitive decline in Alzheimer’s disease Adults with early Alzheimer's disease and/or mild cognitive impairment 2026
The LUCINDA Trial The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA) Tracy Butler, Joan and Sanford I Weill Medical College of Cornell University Lupron, a small molecule gonadotropin-releasing hormone (GnRH) receptor agonist to slow cognitive decline in women with mild to moderate Alzheimer's disease Women with mild-moderate Alzheimer's disease who are also taking acetylcholinesterase (AChE) inhibitors (Ages 65 - 90) 2025
PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health TBD John Rinehart, Neutherapeutics, Llc PhytoSERM, a selective estrogen receptor beta (ERß) modulator; a rationally designed formulation of 3 phytoestrogens, genistein, daidzein, and S-equol Peri- and post-menopausal women (Ages 45 - 60) 2024
PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial TBD Roberta Brinton, University of Arizona PhytoSERM, a selective estrogen receptor beta (ERß) modulator to improve brain metabolism and cognitive function Peri- and post-menopausal women (Ages 45 - 60) 2027
Inflammation
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
First-in-Human (Phase 1) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimer's Disease (AD) A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) Eti Yoles, Immunobrain Checkpoint Inc. IBC-Ab002, an antibody therapy targeting the peripheral immune system Individuals with early Alzheimer's disease (Ages 50 - 75) 2024
Development of a Stress Kinase Inhibitor Therapeutic Candidate for Alzheimer's Disease and Related Dementia MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease (SKI-AD) Jeffrey Pelletier, Neurokine Therapeutics MW150, a small molecule inhibitor of p38alphaMAPK serine/threonine protein kinase to reduce neuroinflammation and improve synaptic function. Mild to Moderate Alzheimer's Disease (Ages 50 - 85) 2024
GM-CSF/Sargramostim Treatment to Improve Cognition in Down Syndrome Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome Huntington Potter, University of Colorado Anschutz Medical Campus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Sargrammostim, an immune system modulator to improve cognition Young adults with Down Syndrome 2024
MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients (MCLENA-1) Marwan Sabbagh, Dignity Health's St. Joseph's Hospital and Medical Center Lenalidomide, a small molecule Anti-inflammatory immunomodulator to reduce neuroinflammation and slow or prevent Alzheimer's disease Adults with amnestic Mild Cognitive Impairment (Ages 50+) 2024
Phase II Trial of GM-CSF/sargramostim in Alzheimer's Disease Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD) Huntington Potter, University Of Colorado Denver Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Sargrammostim, an immune system modulator to improve cognition Older adults with mild-to-moderate Alzheimer's disease 2024
BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (BEACH) Daniel Hanley, Johns Hopkins Bayview Medical Center MW150, a small molecule inhibitor of p38alphaMAPK serine/threonine protein kinase to reduce neuroinflammation and improve synaptic function Participants with spontaneous, non-traumatic, Intracranaial Hemorrhage 2025
Central and Peripheral Immune Cross-Talk in Alzheimer's disease and their Modulation by a Novel Immunotherapy TBD Alireza Faridar, Houston Methodist Hospital Research Institute Low-dose Interleukin-2 (IL-2) immunotherapy to reduce neuroinflammation and ameliorate Alzheimer's disease pathology Participants with Alzheimer's disease (Ages 55 - 86) 2025
Metabolism and Bioenergetics
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia Fei Du, McLean Hospital Nicotinamide riboside (NR), an orally bioavailable precursor of NAD+, to enhance mitochondrial function, and improve cognition Adults with mild cognitive impairment and mild Alzheimer’s disease (Ages 55 - 89) 2025
Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial of T3D-959 in Mild to Moderate Alzheimer's Disease Subjects Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects John Didsbury, T3D Therapeutics, Inc. T3D-959, a small molecule peroxisome proliferator-activated receptor (PPAR)-delta and PPAR-gamma agonist to improve cognition in Alzheimer's disease Adults with mild to severe Alzheimer's disease (Ages 50 - 90) 2023
Phase II Randomized Controlled Trial of Benfotiamine in Early Alzheimer's Disease TBD Gary Gibson, Winifred Masterson Burke Medical Research Institute Benfotiamine, a small molecule thiamine derivative to improve cognition and overall global function Individuals with early Alzheimer's disease, including mild cognitive impairment and mild dementia with plasma evidence of amyloid positivity 2027
Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults The Effect of NAD Supplementation on Brain Vascular Health in Aging Andriy Yabluchanskiy, University of Oklahoma Nicotinamide Adenine Dinucleotide (NAD) supplementation to improve brain health and memory Older adults (Ages 60 - 85) 2027
NAD+ Therapy for Improving Memory & Cerebrovascular Function in Patients with MCI NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults with Mild Cognitive Impairment Christopher Martens, University of Delaware Nicotinamide Riboside, a precursor molecule of Nicotinamide adenine dinucleotide (NAD+) to improve cerebrovascular function and improve memory in patients with mild cognitive impairment People with amnestic mild cognitive impairment (Ages 60 - 90) 2024
The Benefits of Nicotinamide Riboside Upon Cognition and Sleep in Older Veterans Benefits of Nicotinamide Riboside Upon Cognition and Sleep Carleara Weiss, State University of New York at Buffalo Nicotinamide riboside (NR) supplementation to enhance cognition by improving objective sleep duration and sleep quality in older persons Older adults with poor sleep quality (Ages 65 - 85) 2024
Multi-Target
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Senolytics to Improve Cognition and Mobility in Older Adults at Risk of Alzheimer’s Disease Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease (STAMINA) Lewis Lipsitz, Hebrew SeniorLife / Hebrew Rehabilitation Center Quercetin and Dasatinib, a senolytic combination, to improve brain blood flow Older adults with slow gate speed and Mild Cognitive Impairment (Ages 70 - 90) 2024
A Proof of Concept Trial of a Sirtuin-NAD+ Activator in Alzheimer's Disease Sirtuin-NAD Activator in Alzheimer's Disease Shalender Bhasin, Brigham and Women's Hospital ß nicotinamide mononucleotide (ßNMN): An NAD+ precursor to slow Alzheimer's disease progression and improve cognition Mild Alzheimer's disease dementia participants 2024
Repurposing Siponimod for Alzheimer's Disease TBD Marwan Sabbagh, Dignity Health's St. Joseph's Hospital and Medical Center Siponimod, an immunomodulatory small molecule used to treat multiple sclerosis and serves as a neuroprotective Individuals with early Alzheimer's disease (Ages 60 - 85) 2026
Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease Vikas Kotagal, University of Michigan Citalopram, a selective serotonin-reuptake inhibitor to test effect on amyloid-beta levels in the visuospatial cortex and visuospatial cognitive abilities in patients with Parkinson’s disease Older adults with Parkinson's disease diagnosis and no active depression (Ages 65+) 2025
Allopregnanolone as Regenerative Therapeutic for Alzheimer's: Phase 2 Clinical Trial Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease (REGEN-BRAIN©) Roberta Brinton, University of Arizona Allopregnanolone, a small molecule that stimulates anti-inflammatory mechanisms and mitochondrial function to regenerate neurons and restore cognition in Alzheimer's disease Adults who are APOE e4 positive and diagnosed with mild Alzheimer's disease (Ages 55+) 2025
Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimer's Disease Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects (CMS121) William Raschke, Virogenics, Inc. CMS121, a small molecule therapy to reduce neuroinflammation Healthy adult volunteers 2024
Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial TBD Kent Hutchison, University of Colorado Anschutz Medical Campus An intervention with full spectrum hemp-derived cannabidiol (CBD) and CBD to determine the influence on Alzheimer's disease biomarkers Older adults with mild cognitive impairment (Ages 55 - 85) 2028
Oxidative Stress
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Age-Related Mild Cognitive Impairment and Novel Protective Role of Glutathione: Implications for Alzheimer's Disease Glutathione in Mild Cognitive Impairment Rajagopal Sekhar, Baylor College of Medicine Glutathione supplementation to improve cognition in Alzheimer's disease Adults with mild cognitive impairment (Ages 65 - 80) 2024
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease Rajagopal Sekhar, Baylor College of Medicine Glutathione supplementation to improve cognition in Alzheimer's disease Adults with mild cognitive impairment and mild Alzheimer’s disease (Ages 55 - 85) 2025
Veri-T: A Phase 1 Placebo-Controlled Trial of Verdiperstat in Semantic Variant Primary Progressive Aphasia Due to Underlying FTLD-TDP Veri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 Pathology (Veri-T-001) Peter Ljubenkov, University of California San Francisco Verdiperistat, a microglial myeloperoxidase inhibitor that modulates proinflammatory microglia Participants with Semantic variant primary progressive aphasia (Ages 18 - 80) 2026
Receptors
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
The Delivery of Essential Fatty Acids to the Brain in Alzheimer's Disease DHA Brain Delivery Trial (PreventE4) Hussein Yassine, University of Southern California Docosahexaenoic acid (DHA) supplementation, a dietary lipid to improve cognition in Alzheimer's disease Healthy adult carriers and non-carriers of APOE e4 (Ages 60 - 80) 2024
Long Term Nicotine Treatment of Mild Cognitive Impairment Memory Improvement Through Nicotine Dosing (MIND) Study (MIND) Paul Newhouse, Vanderbilt University Medical Center Nicotine to improve cognition in Alzheimer's disease People with mild cognitive impairment (Ages 55+) 2024
A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Alzheimer's Disease Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 Adam Mecca, Yale University BMS-984923, blocks aberrant Amyloid beta activation of mGluR5 Adults with early Alzheimer's disease (Ages 50 - 80) 2024
Health of the Cholinergic System and Risk for Alzheimer's Disease in Postmenopausal Women Cholinergic Health After Menopause (CHAMP) Julie Dumas, University of Vermont and State Agricultural College Mecamylamine, a cholinergic antagonist, to study the relations between the cholinergic system's functional integrity, cognition, and known Alzheimer's disease biomarkers Postmenopausal women (Ages 50 - 70) 2024
Preclinical and Early Clinical Development of a GABA-A a5 PAM TBD Sharon Rosenzweig-Lipson, AgeneBio, Inc. BPN-27473, a potent, selective and orally active GABA-A a5 Positive Allosteric Modulator (PAM) for the treatment of mild cognitive impairment due to Alzheimer's disease Healthy Older Adults 2026
A Randomized Double-blind Placebo Controlled Phase 1 SAD Study in Male and Female Healthy Volunteers to Assess Safety, Pharmacokinetics, and Transient Biomarker Changes by the ABCA1 Agonist CS6253 A Phase 1 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of CS6253 in Healthy Volunteer Jan Johansson, Artery Therapeutics, Inc. CS6253, an ABCA1 transporter agonist to treat APOE4 associated dementia Healthy young adults 2023
Synaptic Plasticity
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
(-)-Phenserine Inhibition of Neuronal Death in Alzheimer’s Disease and Developing Brain-Labeled Plasma Exosomes Assays as Biomarkers for a Phenserine Phase 1b Ascending Dose Trial TBD Lon S. Schneider, University of Southern California (-)-PHENSERINE, a small molecule that inhibits neuronal pre-programmed cell death, to prevent neuronal dysfunction and death Adults with probable Alzheimer's disease (Ages 70 - 82) 2024
Treating Hyperexcitability in Alzheimer’s Disease with Levetiracetam to Improve Brain Function and Cognition Treating Hyperexcitability in AD With Levetiracetam (LeAD) Mouhsin Shafi, Beth Israel Deaconess Medical Center Levetiracetam, a small molecule synaptic vesicle protein (SV2A) modulator, to improve cognition in Alzheimer's disease Adults with probable Alzheimer's disease (Ages 50 - 90) 2023
A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Impact of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia with Lewy Bodies (DLB) Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies Charbel Moussa, Georgetown University Nilotinib, a small molecule inhibitor of Abelson kinase to facilitate degradation of neurotoxic proteins and promote survival of neurons Adults with clinical diagnosis of Lewy body dementia with both dementia and Parkinsonism (Ages 25 - 90) 2024
Development of a Small-molecule that Enhances Tripartite Synapses for Alzheimer's Disease TBD Chien-Liang Glenn Lin, Ohio State University A single ascending dose (SAD) study to determine safety and tolerability of a novel compound that has the potential for modifying Alzheimer's disease progression/onset Healthy men and women (Ages 18 - 60) 2024
Tau
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
First in Human Study of a Tau Self-Association Small Molecule Inhibitor in Healthy Volunteers TBD William Erhardt, Oligomerix, Inc OLX-07010 is a tau self-association inhibitor small molecule that targets tau, a protein involved in disease progression Healthy adults (ages 18 - 50) and healthy older adults (ages 51 - 75) 2024
The Alzheimer's Disease Tau Platform Clinical Trial TBD Adam Boxer, University of California San Francisco Tau-directed therapies, alone and in combination with an anti-amyloid therapy, to slow Alzheimer's disease progression Older adults with elevated brain amyloid and tau (Ages 60 - 75) 2028
Vasculature
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid and Tau in Older Adults (IPAT-study) Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study) (IPAT) Rong Zhang, University of Texas Southwestern Medical Center Intensive lowering of systolic blood pressure (SBP) using antihypertensive medications to reduce Alzheimer's disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia Older adults who have hypertension (SBP=130 mmHg), family history of dementia, and/or subjective memory complaints (Ages 60 - 80) 2027
Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis of Aging (SMArT–HS) Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis of Aging (SMArT-HS) Gregory Jicha, University of Kentucky Nicorandil, a small molecule agonist for sulfonyl urea receptor 2 protein (SUR2), to improve cognition and hippocampal pathology Adults with probable Hippocampal sclerosis (HS)-aging (Ages 75+) 2025
Hypertension, Intracranial Pulsatility and Brain A-beta Accumulation in Older Adults Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial) (HIPAC) Rong Zhang, University of Texas Southwestern Medical Center Amlodipine (calcium channel blocker), Losartan (angiotensin II receptor blocker), and other antihypertensive drugs to reduce systolic blood pressure and alter brain function Older adults with hypertension (Ages 55 - 79) 2024
Arterial Stiffness, Cognition, and Equol (ACE) Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers (ACE) Akira Sekikawa, University of Pittsburgh Equol supplementation as an intervention to improve cognitive decline by targeting arterial stiffness and white matter lesions in the brain Older adults (Ages 65+) 2027
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults (Mito-Frail) Oh Sung Kwon, University Of Connecticut Storrs Determine if MitoQ supplementation will affect peripheral vasodilation, peripheral and cerebral nitric oxide (NO) bioavailability and mitochondrial reactive oxygen species (mtROS), cognitive function and gait speed Older adults who are healthy, frail with slow walking speed (0.4m/s based on a 4m walk), and those who meet criteria for mild cognitive impairment (Ages 65 - 80) 2028
Other
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Phase II RCT of High-Dose Vitamin D Supplements in Older Adults Without Dementia High-dose Vitamin D Supplements in Older Adults John Olichney, University of California Davis Vitamin D supplements, to improve cognitive outcomes in elderly groups at risk for dementia People with mild cognitive impairment or mild Alzheimer’s disease (Ages 65 - 90) 2024
Anti-Viral Therapy in Alzheimer's Disease Anti-viral Therapy in Alzheimer's Disease Davangere Devanand, Columbia University Valacyclovir, an Antiviral (Herpes Simplex Virus drug) to examine if HSV contributes to the pathology of Alzheimer's disease and whether antiviral treatment can improve cognition People with mild Alzheimer's disease 2024
The Use of Deferiprone to Improve Subarachnoid Hemorrhage Cognitive Outcome: U-DISCO Ferritin and Iron Burden in SAH sIRB David Hasan, Duke University Deferiprone to improve cognitive outcomes Adults with aneurysmal subarachnoid hemorrhage at risk for cognitive decline (Ages 18 - 70) 2025
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder TBD Michael Howell, University of Minnesota Twin Cities Compare serotonergic rapid eye movement (REM) sleep Behavior Disorder (5-HT RBD) participants and to adults without RBD who are taking a serotonergic antidepressants in order to: (1) detect systemic alpha-synuclein pathology; (2) examine for evidence of brainstem neurodegeneration using 7T magnetic resonance imaging; (3) quantify evolving speech deficits Adults with serotonergic rapid eye movement (REM) sleep Behavior Disorder (5-HT RBD) and adults without RBD who take serotonergic antidepressants (Ages 18 - 75) 2028

Section 2: Clinical Drug Development – Phase II/III and Phase III

Amyloid
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
The A3 Study: Ante-Amyloid Prevention of Alzheimer's Disease AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid Reisa Sperling, University of Southern California BAN2401 , anti-amyloidß antibody to prevent cognitive decline in Alzheimer's disease by preventing amyloid accumulation Cognitively healthy older adults with "intermediate" amyloid levels on screening PET (Ages 55 - 80; adults 55 - 64 must also carry at least one APOE e4 allele) 2024
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss (A4) Reisa Sperling, Brigham And Women's Hospital Solanezumab, an anti-amyloidß antibody to prevent cognitive decline associated with early Alzheimer's disease pathology Cognitively healthy older adults who are amyloid positive on brain imaging (Ages 65+) 2024
Combination Anti-amyloid Therapy for Preclinical Alzheimer's Disease (A-45) AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid Paul Aisen, University of Southern California BAN2401, anti-amyloidß antibody to slow or prevent cognitive decline in cognitively normal preclinical individuals with Alzheimer's disease Cognitively healthy older adults with "elevated" amyloid levels on screening PET (Ages 55 - 80; adults ages 55 - 64 must have an additional risk factor) 2025
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4) Susan Abushakra, Alzheon Inc. ALZ-801 (tramiprosate pro-drug), an inhibitor of Aß oligomer formation Individuals with APOE e4 and early Alzheimer's disease diagnosis 2025
DIAN-TU Primary Prevention Trial TBD Eric Mcdade, Washington University in St. Louis Anti-amyloid therapy to prevent Alzheimer's disease Cognitively healthy adults who are Alzheimer's disease genetic mutation carriers 2026
Circadian Rhythm
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep with Trazodone (Rest) Targeting Cognition in Early Alzheimer's Disease by Improving Sleep with Trazodone (REST) Barry Greenberg, Johns Hopkins Bayview Medical Center Trazadone, an antidepressant to treat sleep disturbance and improve cognitive outcomes Individuals with prodromal Alzheimer's disease or amnestic Mild Cognitive Impairment and sleep complaints 2026
Inflammation
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Mild-to-Moderate Dementia with Lewy Bodies (DLB) A Clinical Study of Neflamapimod in Patient with Dementia with Lewy Bodies JJohn Alam, Eip Pharma, Inc. Neflamapimod, inhibitor of p38 mitogen activated protein kinase alpha (p38a), to reduce neuronal degeneration Mild-to-moderate dementia with Lewy bodies (Ages 55+) 2026
Metabolism and Bioenergetics
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Metformin in Alzheimer's Dementia Prevention Metformin in Alzheimer's Dementia Prevention (MAP) Jose Alejandro Luchsinger, Columbia University Metformin, a medication with proven efficacy in decreasing hyperinsulinemia and preventing diabetes, repurposed for the prevention of Alzheimer’s dementia Adults with amnestic mild cognitive impairment (Ages 55 - 90) 2025
Multi-target
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Evaluation of Brain and Cognitive Changes in Older Adults with MCI Taking Lithium to Prevent Alzheimer Type Dementia Lithium As a Treatment to Prevent Impairment of Cognition in Elders (LATTICE) Ariel Gildengers, University of Pittsburgh Lithium, a GSK3a and GSK3ß inhibitor to prevent or slow cognitive decline in older adults with mild cognitive impairment People with mild cognitive impairment (Ages 60+) 2024
Depression Treatment and Aβ dynamics: A Study of Alzheimer’s Disease Risk Aß Dynamics in LLMD Nunzio Pomara, New York University School of Medicine Escitalopram Oxalate, a SSRI antidepressant to examine effects of Alzheimer's disease biomarkers Older cognitively unimpaired adults with Major Depressive Disorder (Ages 60+) 2026
Receptors
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH) Alison Huang, University of California San Francisco Tolterodine and Mirabegron, anticholinergic bladder medications Older women with urinary incontinence and without pre-existing dementia 2027
Tau
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
DIAN-TU: Tau Next Generation Prevention Trial (Fourth Drug Arm) and DIAN-TU: Tau Next Generation Prevention Trial (Fifth and Sixth Drug Arm) Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. (DIAN-TU) Randall Bateman, Washington University in St. Louis Anti-tau therapy to prevent AD Cognitively healthy or mildly impaired adults who are Alzheimer's disease genetic mutation carriers 2026
Vasculature
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
PRagmatic EValuation of evENTs And Benefits of Lipid-Lowering in oldEr Adults (PREVENTABLE) Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE) Karen Alexander, Duke University Atorvastatin, a statin to reduce death, dementia, and persistent disability Community-dwelling adults without clinically evident cardiovascular disease, significant disability, or dementia (Ages 75+) 2027
Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline (IMPACTS-MIND) Katherine Mills, Tulane University Multifaceted intensive blood pressure intervention to reduce blood pressure-related cognitive decline in underserved populations Adults with hypertension who receive primary care from clinics that predominately manage underserved populations with health disparities 2025

Section 3: Non-drug

Cognitive Training
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Losing specificity: The Role of the Locus Coeruleus in Age-Related Distractibility The Role of the Locus Coeruleus in Age-related Distractibility Tae-Ho Lee, Virginia Polytechnic Institute and State University Two interventions to facilitate neural plasticity in the brain, either multi-modal adaptive attention training or practice on a training version of the criterion attention task, to examine how this may modulate locus coeruleus-salience network connectivity and mitigate distractibility Healthy participants from the Roanoke and Blacksburg metropolitan area in Virginia (Ages 55 – 75) 2027
Developing a Mobile App-Based Intervention to Promote Cognitive Health in Older Chinese Americans Cognitive Training RCT for Older Chinese Americans Hanzhang Xu, Duke University A mobile app-based cognitive training (aka mHealth) intervention that is culturally and linguistically relevant to older Chinese Americans to, ultimately, enhance cognitive function in the population. Includes dementia knowledge education, culturally-appropriate app content, cognitive training activities, and training reminders. Older Chinese Americans without cognitive impairment and adult children of older Chinese Americans 2024
Understanding Individual Differences in Working Memory Training and Transfer in Older Adults at Risk of Alzheimer's Disease and Related Dementias Understanding Individual Differences in Working Memory Training and Transfer in Older Adults Aaron Seitz, University of California Riverside Cognitive training program focused on working memory systems and the role of inhibitory control, to promote health and general cognition Older adults at risk for Alzheimer's disease and related dementias (AD/ADRD) 2023
Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE) Mouna Attarha, Posit Science Corporation INHANCE, a computerized cognitive training program based on neuroplasticity principles to reduce long-term risk of dementia Healthy older adults (Ages 65+) 2024
ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia Jerri Edwards, University of South Florida Combination of cognitive training exercises to modify the functional trajectories of adults with mild cognitive impairment Older adults with mild cognitive impairment (Ages 65 - 89) 2027
Elucidating the Necessary Components and Mechanisms of Cognitive Training Elucidating the Necessary Active Components of Training (ENACT) Lesley Ross, Clemson University Bottom-up driven process-based training (BUD) and top-down driven training (TDD), two types of strategy-based cognitive training to improve cognition Adults (Ages 45-90) 2023
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining) Davangere Devanand, Columbia University Computerized cognitive training to improve cognitive performance People with Mild Cognitive Impairment (Ages 55 - 95) 2024
Patient-Centered Serious Games for Remote Cognitive Training in Older Adults with Mild Cognitive Impairment Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic Ivan Lee, University of Massachusetts Boston Serious games (Neuro-World), to stimulate working memory and improve cognition Older adults with Mild Cognitive Impairment 2024
Mitigating Cancer-related Cognitive Dysfunction in Older Adults With Breast Cancer Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment Allison Magnuson, University of Rochester Memory and Attention Adaptation Training-Geriatrics (MAAT-G), a cognitive behavioral therapy-based intervention comprised of a series of videoconferencing workshops Older cancer survivors with Mild Cognitive Impairment (Ages 65+) 2024
The Adherence Promotion with Person-centered Technology (APPT) Project: Promoting Adherence to Enhance the Early Detection and Treatment of Cognitive Decline Smart Reminders to Promote Home-based Cognitive Training Walter Boot, Florida State University Mobile platform-based support system intervention to improve adherence to home-based cognitive assessment Non-cognitively impaired adults (Ages 65+) 2024
Prospective Memory Impairment in Parkinson Disease-related Cognitive Decline: Intervention and Mechanisms Everyday Memory Impairment in PD-related Cognitive Decline (PMT2) Erin Foster, Washington University in St. Louis Memory encoding strategies to improve prospective memory Adults who meet criteria for typical idiopathic Parkinson's disease (Ages 50+) 2025
Early Cognitive Training and Rehabilitation to Prevent Cognitive Decline in Older Hospitalized Adults with Delirium Early Cognitive Intervention in Delirium (ECID) Jin Han, Vanderbilt University Medical Center Cognitive training rehabilitation program for individuals with delirium to improve working memory Hospitalized older delirious patients with and without Alzheimer's disease and related dementias (Ages 65+) 2025
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke Edward Taub, University of Alabama at Birmingham Web-based computer game that trains cognitive processing speed to improve everday activities Stroke Patients 2025
Cognitive Training to Reduce Incidence of Cognitive Impairment in Older Adults Preventing Alzheimer's Disease with Cognitive Training (PACT) Jerri Edwards, University of South Florida Speed of processing training intervention to reduce incidence of mild cognitive impairment or dementia Older adults who are cognitively normal 2026
Use of the KF Modified Story Memory Technique to Improve New Learning and Memory in Individuals with Mild Cognitive Impairment Improve New Learning and Memory in Individuals With Mild Cognitive Impairment Nancy Chiaravalloti, Kessler Foundation, Inc. Kessler Foundation modified Story Memory Technique (KF-mSMT), a 10-session structured cognitive rehabilitation treatment composed of the application of imagery and context to facilitate learning Older adults with mild cognitive impairment and no evidence of dementia (Ages 60+) 2027
Web-Based Technology and Cognitive Training: Improving Executive Control in Cognitively Healthy Older Adults Using Teleneuropsychology to Optimize Cognition in Healthy Aging: The Web-based Breakfast Game Sharon Sanz Simon, Columbia University The intervention includes a web-based cognitive training of Executive Control (EC) using an ecological Emphasis Change (EmCh) approach with a task named the Breakfast Game (B-Game) Cognitively healthy older adult participants (Ages 60 - 75) 2024
Neuromechanisms of Falls in Older Adults with MCI: Targeting Assessment and Training of Reactive Balance Control Dual Task Perturbation Training for OAwMCI Tanvi Bhatt, University of Illinois at Chicago A novel four-week perturbation-based cognitive-motor intervention for improving reactive balance control and cognition Older adults with mild cognitive impairment or cognitively intact older adults (Ages 55+) 2026
Using Artificial Intelligence to Predict Cognitive Training Response in Amnestic Mild Cognitive Impairment Training Response Artificial Intelligence Network (TRAIN) Joseph Gullett, University of Florida Use of artificial intelligence in cognitive training for memory deficit-based disorders, which may increase the risk of Alzheimer’s disease Adults with amnestic mild cognitive impairment (Ages 55 - 100) 2028
Develop an ANS-based Personalized Cognitive Training for Mild Cognitive Impairment CogT pSOPT Intervention Study Feng Lin, Stanford University Personalized cognitive training program to slow cognitive decline; intervention is tailored using a participant's biofeedback and cognitive performance People with mild cognitive impairment due to Alzheimer's disease (Ages 60 - 89) 2026
Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure Miyeon Jung, Indiana University-Purdue University Indianapolis Preliminary efficacy study of a combined intervention involving virtual reality-based cognitive restoration (Vita) coupled with computerized cognitive training (Com), compared to each intervention alone, and standard of care in a 4-group randomized controlled trial using a 2X2 factorial design Dyads composed of older (65+ years) patients with HF (chronic HF Stage C validated from echocardiography or comparable measure) and MCI (MoCA score 23 and lower) and their informants 2027
Combination Therapy
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial) The ACT Trial: Effects of Combined Aerobic Exercise and Cognitive Training in MCI Fang Yu, Arizona State University Aerobic exercise (cycling) and a specific type of cognitive training (speed of processing training) intervention to improve reasoning and memory, as well as to improve brain structure and function People with Mild Cognitive Impairment (Ages 65 - 74) 2024
MIND Food and Speed of Processing Training in Older Adults with Low Education MINDSpeed Food and Brain Training RCT (MINDSpeed) Daniel Clark, Indiana University-Purdue University Indianapolis Nutrition intervention (with foods high in polyphenols) combined with cognitive training exercises to test impact on cognitive performance Older adults (60+) 2024
Influence of Strategy Training on Disability for Older Adults with Mild Cognitive Impairment Facilitating Optimal Routines in Aging (ForAging) Juleen Rodakowski, University of Pittsburgh Strategy Training to slow the emergence of disability and decline in cognition People with Mild Cognitive Impairment (Ages 60+) 2023
Digital Multidomain Lifestyle Intervention to Address Cognitive Health and Modifiable Risk Factors for Alzheimer's Disease Reducing Dementia Risk With Digital Health Coaching (DC-MARVEL) Jordan Glenn, Neurotrack Technologies MindMate + Health Coaching, a digital intervention consisting of the MindMate cognitive health app (digital multi-domain lifestyle intervention designed to address modifiable risk factors for dementia) and Neurotrack's personalized health coaching platform At-risk adults (Ages 45 - 64) 2024
Neuro-exergaming for the Prevention and Remediation of Decline Due to Alzheimer's Disease and Related Dementias: A Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES v3) The Interactive Physical and Cognitive Exercise System (v3) for Mild Cognitive Impairment (MCI) (iPACES) Cay Anderson-Hanley, iPACES LLC iPACES v3, a physical and cognitive exercise system that can be used at home People with Mild Cognitive Impairment or subjective cognitive complaints (Ages 50+) 2024
Targeted Physical and Cognitive Activity in a VR Environment in Older Adults at Risk for Alzheimer's Disease TBD Judy Pa, University of California San Diego Physical and cognitive activity program in a virtual reality environment to improve cognition People with early Mild Cognitive Impairment (Ages 55 - 80) 2026
Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment Sleep Interventions and Neurocognitive Outcomes Hyun Kim, New York State Psychiatric Institute Research Foundation For Mental Hygiene, Inc. Assess the neurocognitive effects of two sleep interventions (cognitive behavioral therapy for insomnia [CBTI] and acoustic slow-wave activity enhancement [SWAE]) and their underlying mechanisms in individuals with amnestic mild cognitive impairment Older adults with sleep disturbance who meet criteria for amnestic mild cognitive impairment (Ages 60 - 85) 2028
MIND Foods and Aerobic Training in Black Adults with HTN: An ADRD Prevention Pilot RCT (MAT) TBD Daniel Clark, Indiana University-Purdue University Indianapolis Mediterranean-Dash Intervention for Neurodgenerative Delay (MIND) and aerobic training (MAT) Non-Hispanic black adults with hypertension (Ages 40 - 64) 2027
Behavioral Interventions for the Treatment of Early Onset Alzheimer's Disease Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study (LITES) Dustin Hammers, Indiana University-Purdue University Indianapolis To conduct behavioral interventions for the management of patients with early-onset Alzheimer’s disease Adults with a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment (Ages 40 - 64) 2028
Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults TBD David Clark, University of Florida Brain electrical stimulation intervention to improve walking performance and executive function in older adults with cognitive decline Older adults with age-related cognitive decline (Ages 65 – 89) 2027
A Multi-modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors TBD Maya Elias, University of Washington Daily 30-minute cognitive training sessions and/or sleep promotion intervention to improve cognitive function and sleep Older adults with no diagnosis of dementia and an intensive care unit stay of 24+ hours (Ages 60+) 2027
Midwest Roybal Center for Health Promotion and Translation: Piloting the i-PROACTIF Program to Preserve Functioning and Prevent Cognitive Decline (Pilot) Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline Mansha Mirza, University of Illinois at Chicago IPROACTIF is an occupational therapist-delivered primary care intervention for aging and chronic disease management Community-dwelling adults (Ages 55+) 2024
Resilience and Brain Health of Older Adults During the COVID-19 Pandemic Resilience and Brain Health of Older Adults During the COVID-19 Pandemic (MEDEX-2) (MEDEX-2) Eric Lenze, Washington University in St. Louis Exercise and mindfulness interventions to measure the effects of COVID-induced stress on AD-related cognitive decline Healthy, sedentary, community living individuals, (Age 65 - 84) 2026
Cognitive and Physical Exercise to Improve Outcomes After Surgery in the Elderly Cognitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study (COPEiOS) Christopher Hughes, Vanderbilt University Medical Center A comprehensive cognitive and physical training program compared to active control to improve outcomes after surgery in the elderly Patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days and high likelihood of ICU admission 2025
Diet and Supplements
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Novel Food-based Approach for Prevention of Age-associated Cognitive Decline in Older Adults with Obesity Nutrition for Brain and Body Health (BB-Health) Feasibility Trial (BB-Health) Susan Roberts, Tufts University Medical School Nutrition-based intervention to improve cognitive and brain functioning Older adults who are overweight/ obese 2024
Modified Ketogenic Diet Effects on Alzheimer's Disease Biomarkers and Cognition in Mild Cognitive Impairment Brain Energy for Amyloid Transformation in Alzheimer's Disease Study (BEAT-AD) Suzanne Craft, Wake Forest University Ketogenic diet to improve cognitive symptoms and pathology in Mild Cognitive Impairment People with amnestic Mild Cognitive Impairment (Ages 55 - 85) 2024
Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk Multicultural Healthy Diet to Reduce Cognitive Decline (MHD) Yasmin Mossavar-Rahmani, Albert Einstein College of Medicine An anti-inflammatory, multicultural health diet (MHD) to improve cognitive function in a culturally diverse population of adults Adults (Ages 40 - 65) 2024
Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders Richard Sloan, Columbia University Cocoa-flavanol supplement to reduce systemic inflammation, improve cerebral blood volume to the hippocampus, and improve cognition Adults (Ages 50 - 69) 2024
Enhanced Mediterranean Diet for Alzheimer's Disease Prevention Nutrition Interventions for Cognitive Enhancement (NICE) Debra Sullivan, University of Kansas Medical Center To investigate the effects of a Mediterranean diet (MedD) that is enhanced with extra virgin olive oil (EVOO), almonds, and omega-3 supplements (Med+O) on cognition, brain volume, cerebral antioxidant status, and cardiometabolic biomarkers in adults without cognitive impairment Adults (Ages 65+) 2024
Validation and Mechanistic Interrogation of Metabolism Targeting for AD Therapeutic Diets in Alzheimer's Disease (TDAD) Russell Swerdlow, University of Kansas Medical Center Ketogenic diet (KD) to test whether manipulating brain energy metabolism through the KD will benefit individuals with Alzheimer's disease People with Alzheimer's disease (Ages 50 - 90) 2024
Brain Healthy Soul Food Diet Intervention Among Older African Americans Brain Healthy Soul Food Diet Intervention Among Older African Americans (MIND+SOUL Diet) Ashley Shaw, University of Kansas Medical Center Culturally-adapted, brain-healthy diet to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older African American adults Older African American adults (Ages 55+) 2025
MIND Diet and Dementia Prevention in Ischemic Stroke Patients Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Neelum Aggarwal, Rush University Medical Center Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND), to test impact on cognition and brain biomarkers related to dementia in patients who are recovering from acute ischemic stroke Individuals who have suffered acute stroke (Ages 60 - 80) 2026
APOE Genotype Effects on Triglycerides and Blood Flow in the Human Brain Apolipoprotein E (APOE) Genotype Effects on Triglycerides and Blood Flow in the Human Brain Angela Hanson, University of Washington Ingestion of a high fat drink (heavy dairy cream) to gain a more in-depth understanding of how high fat feeding (HFF) exerts influence on brain function and metabolism for APOE e4 carriers and non-carriers, and identify brain regions which are particularly vulnerable to the acute effects of HFF Older adults with and without APOE E4 (Ages 55+) 2025
Caffeine and Postoperative Neurocognitive Recovery The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study Phillip Vlisides, University of Michigan Test the effects of caffeine on neurocognitive and clinical recovery after major surgery Adult surgical patients presenting for major non-cardiac, non-intracranial, non-major vascular surgery (Ages 70+) 2027
Exercise
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Investigating Gains in Neurocognition in an Intervention Trial of Exercise Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) Kirk Erickson, University of Pittsburgh Exercise program to decrease cognitive decline associated with aging Sedentary adults (Ages 65 - 80) 2024
Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife Jonathan Hakun, Penn State Health Milton S. Hershey Medical Center

Adaptive Step Goals with Interim Goal Setting: participants receive daily step goals, self-monitoring, and interim goal setting on study smart phone to promote increased goal maintenance

Middle-aged adults with increased risk for Alzheimer's disease and related dementia due to obesity 2027
Exercise to Improve Hippocampal Connectivity and Learning in Older Adults Exercise Effects on Brain Health and Learning From Minutes to Months (EXTEND) Michelle Voss, University of Iowa Exercise program to improve learning and increase functional hippocampal-cortical communication that otherwise declines with aging Sedentary Adults (Ages 55 - 80) 2024
Exercise for Brain Health with Increased Genetic Risk for Alzheimer's Disease Exercise for Brain Health in the Fight Against Alzheimer's Disease Jerome Smith, University of Maryland Exercise and flexibility training programs to improve quality of life and physical function Physically inactive adults (Ages 60 - 80) 2024
Mechanical Integrity of Memory Systems in Mild Cognitive Impairment Aging Brain Structure and Memory in Response to Exercise Curtis Johnson, University of Delaware To study how the mechanical integrity of the brain changes during aging and in response to 3 months of exercise therapy, measured by determining viscoelastic properties through magnetic resonance elastography (MRE) Healthy participants and participants with amnestic Mild Cognitive Impairment (Ages 65+) 2024
The Effect of Physical Activity on Cognition Relative to APOE Genotype (PAAD-II) Physical Activity, Alzheimer's Disease and Cognition Relative to APOE Genotype (PAAD-2) Jennifer Etnier, University of North Carolina at Greensboro Physical Activity program intervention to delay the onset of Alzheimer's disease Adults with a family history of Alzheimer's disease (Ages 40 - 65) 2024
Rhythm Experience and Africana Culture Trial Rhythm Experience and Africana Culture Trial (REACT) Kirk Erickson, University of Pittsburgh To investigate whether African Dance improves cognitive, neurological, physical, psychosocial, and mood outcomes in 60- to 80-year-old African Americans African Americans (Ages 60 - 80) 2024
Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Robert Newton, Louisiana State Univ Pennington Biomedical Research Center Aerobic exercise & strength training programs to promote cognitive function in older African American adults African American adults (Ages 65 - 85) 2025
FitMi AD: A Safe and Motivating Computer-guided Exercise System for Individuals with MCI or Mild Dementia Due to Alzheimer's Disease FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease Daniel Zondervan, Flint Rehabilitation Devices (FlintRehab) FitMi AD system, a wireless, sensorized at-home exercise device Individuals with mild cognitive impairment or mild dementia 2024
Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-of-Concept Trial Goal Setting to Promote Physical Activity Adherence Molly Maxfield, Arizona State University The intervention is a Physical Activity (PA) Goal Setting Technique Adults with BMI of 30 kg/m2 or greater (Ages 45 - 65) 2024
Brain Health Together: A Live-streaming Group-based Digital Program TBD Cynthia Benjamin, RH Studio 2 OpCo 22, Inc. Brain Health Together, a 12-week, group-based, live streaming, digital program focused on addressing physical activity and social isolation to improve cognitive function People living with mild cognitive impairment 2024
Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment Fuzhong Li, Oregon Research Institute Tai Ji Quan (martial arts practice) intervention to slow cognitive decline in older adults with mild cognitive impairment People with Amnestic Mild Cognitive Impairment (Ages 65+) 2024
Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease Madeleine Hackney, Emory University Partnered Rhythmic Rehabilitation, an intervention that simultaneously targets cardiovascular, social and motor-cognitive domains, to improve motor-cognitive function, and neuronal, vascular and inflammatory intermediaries Adults with prodromal Alzheimer's disease (Ages 50 - 80) 2024
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults with Down Syndrome The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome Lauren Ptomey, University of Kansas Medical Center Moderate-to-vigorous physical activity in adults with down syndrome to prevent Alzheimer's disease Adults with down syndrome (Ages 18+) 2024
Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline (BDJ) Jian Kong, Massachusetts General Hospital Baduanjin (BDJ), a mind-body exercise to reduce cognitive decline Adults (Ages 50 - 80) 2024
A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos G. Adriana Perez, University of Pennsylvania "Tiempo Juntos para la Salud," a multilevel intervention for Latino adults with mild cognitive impairment that includes empowerment education for behavior change and individual motivation, building support network, and promoting community resources for safe walking to reduce inactivity Spanish language dominant Latino adults with mild cognitive impairment (Ages 55+) 2024
Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease (AEROBIC) Jill Morris, University of Kansas Medical Center Exercise intervention to characterize the brain metabolic response to different exercise intensity levels and measure changes in cognition People with Alzheimer's Disease (Ages 60+) 2025
Yoga, Aerobic and Stretching Exercise Effects on Neurocognitive Performance: A Randomized Controlled Trial Yoga, Aerobic and Stretching Exercise Effects on Neurocognition Neha Gothe, University of Illinois Yoga training and aerobic exercise programs to test effects on cognitive functions, neural activity and structure, and physiological parameters Adults with normal cognition (Ages 55 - 79) 2025
CYCLE-AD: Randomized Controlled Trial to Assess the Efficacy of Indoor Cycling in Slowing Disease Progression in Healthy Older Persons at Genetic Risk for Alzheimer's Disease CYCLE-AD (CYcling to Cease or Limit the Effects of Alzheimer's Disease) (CYCLE AD) Stephen Rao, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University Indoor Cycling (high intensity; 60-90% of heart rate reserve) to slow or delay disease onset Healthy elders at genetic risk for Alzheimer's disease; APOE e4 carriers (Ages 65 - 80) 2025
Determinants of Individual Differences in the Efficacy of Aerobic Exercise to Improve Brain Health and Reduce Alzheimer Disease Risk in Older African Americans Exercise to Improve Brain Health in Older African Americans Mark Gluck, Rutgers University Newark Cardio Dance Fitness (CDF) intervention, and a Strength, Flexibility, & Balance intervention Sedentary older African Americans (Ages 60+) 2027
Reducing African Americans Alzheimer's Disease Risk Through Exercise-MCI Cohort (RAATE-MCI) Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI) (RAATE-MCI) Robert Newton, Louisiana State Univ Pennington Biomedical Research Center Exercise intervention to reduce risk in African Americans with Mild Cognitive Impairment African Americans with mild cognitive impairment (Ages 65 - 85) 2026
Differential Effects of Exercise Modality on Cognition and Brain in Older Adults Combined Exercise Trial (COMET) Eric Vidoni, University of Kansas Medical Center Aerobic and resistance exercise programs, to test combined and independent effects on cognitive, neural, and physical function Healthy individuals (Ages 65 - 80) 2026
Establishing the Optimal Frequency of Dance Movement for Neurocognitive and Physical Outcomes in People at Risk of Alzheimer's Disease Effects of Dance and Music Appreciation on Brain Health and Fitness in People at Risk for Alzheimer's Disease (IGROOVE) Christina Hugenschmidt, Wake Forest University Dance movement and music appreciation classes to improve cardiorespiratory fitness and cognition Adults at risk for Alzheimer's disease due to subjective cognitive decline (Ages 65+) 2027
Influence of Exercise Training and Intensity on Cerebral Blood Flow Regulation and Cognitive Function in Mid-Life Adults With Cardiovascular Disease Cardiac Rehab and Cerebral Blood Flow Study Jenna-Lee Taylor, Mayo Clinic Rochester Exercise intervention, comparing effects of High Intensity Interval Training (HIIT) vs. Medium Intensity Continuous Training (MICT) on cognitive function Mid-life adults with cardiovascular disease 2024
Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease Laura Korthauer, Rhode Island Hospital A 24-session healthy living education program, with enhanced content about health beliefs and mechanisms of behavior change Cognitively healthy/normal adults with at least two Alzheimer's disease risk factors (Ages 45 - 69) 2024
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity (EXEC-study) Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity (EXEC) Ulf Bronas, University of Illinois at Chicago Home-based walking program to improve cognitive function in patients with co-morbid chronic kidney disease and mild cognitive impairment Older adults with mild cognitive impairment and chronic kidney disease 2027
Dual-Task Training Exercise to Reduce Falls in Older Adults with Mild Cognitive Impairment TBD Fuzhong Li, Oregon Research Institute A three-arm, single-blind, randomized controlled trial comparing efficacy of the two tai ji quan fall prevention interventions (Dual-TJQMBB, standard TJQMBB) relative to a stretching control for reducing the incidence of falls among older adults with mild cognitive impairment Adults with mild cognitive impairment (Ages 65+) 2028
TeleExergame: An Interactive Tele-Rehabilitation Platform for Improving Motor Function in Older Adults with Cognitive Deficit Remote Game-based Exercise Program for Cognitive and Motor Function Improvement Bijan Najafi, BioSensics A tele-exercise system that allows a qualified therapist to remotely supervise and interact with the patient during goal-oriented game-like and low risk exercise tasks that have been designed to improve balance and cognition Individuals with Mild Cognitive Impairment and/or mild dementia 2024
Natives Engaged in Alzheimer's Research: IKE Kupuna (Elder Wisdom) Project Natives Engaged in Alzheimer's Research - 'Ike Kupuna (NEAR) Joseph Kaholokula, Washington State University A tailored Hula dance program to prevent or slow cognitive decline Older Native Hawaiians Pacific Islanders with uncontrolled hypertension (Ages 55+) 2026
Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease: LEAN Lactate for Energy and Neurocognition (LEAN) Jill Morris, University of Kansas Medical Center Aerobic exercise and lactate infusions to understand changes in brain glucose metabolism and promote cognition Cognitively normal people and people with Alzheimer's disease (Ages 60 - 90) 2025
Precision Medicine in Alzheimer’s Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-fitness Responses A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses (SMART) Fang Yu, Arizona State University Aerobic exercise program to improve cognition and memory People with mild Alzheimer’s disease (Ages 65+) 2028
Midwest Roybal Center for Health Promotion and Translation: Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis (Pilot) Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis Peixuan Zheng, University of Illinois at Chicago Remotely-delivered aerobic and resistance exercise training to improving cognitive and physical function Adults diagnosed with multiple sclerosis who have cognitive and walking impairment (Ages 50+) 2024
Boston Roybal Center for Active Lifestyle Interventions: Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease (HABS) (Pilot) Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease (HABS) Maiya Geddes, Douglas Mental Health University Institute The Intergenerational Social Motivation Behavioral Intervention is a technology-based platform to enhance physical activity in older adults at risk for Alzheimer’s disease Cognitively normal older adults with a first-degree family history of Alzheimer's disease (Ages 60+) 2024
mHealth-facilitated Physical Activity Toward Health (mPATH) for Cognitive Function and Sleep in Low-income Older Adults mPATH for Low-income Older Adults Junxin Li, Johns Hopkins Bayview Medical Center Personalized physical activity intervention to improve cognition and sleep Sedentary low-income older adults with sleep difficulties (Ages 65+) 2028
Midwest Roybal Center for Health Promotion and Translation: We Walk Plus Study: A Walking Program using Physical Activity Monitors and Social Network for Older Adults with Intellectual Disabilities (Pilot) We Walk Plus Study for Older Adults With Intellectual Disabilities Kueifang Hsieh, University of Illinois at Chicago We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities Older adults with intellectual disabilities 2024
A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-level Intervention to Increase Physical Activity in Adults with Intellectual Disability: Step it Up+ TBD Brianne Tomaszewski, University of North Carolina at Chapel Hill Fitness classes and coaching for persons with intellectual disabilities to increase physical activity People with intellectual disabilities and no clinically elevated symptoms of Alzheimer's disease or related dementias (Ages 18+) 2028
Developing of a Computer-based Multimodal Mind and Body Approach for Mild Cognitive Decline TBD Jian Kong, Brain Thrive Technology LLC Digital self-directed multimodal mind and body approach intervention that integrates Baduanjin, acupressure, and relaxation to improve the cognitive function for mild cognitive impairment Individuals with mild cognitive impairment (Ages 55+) 2024
Examining the Effect of High-intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living with HIV (HEALTH-Cog) TBD Pariya Wheeler, University of Alabama at Birmingham Physical activity (High-intensity interval training versus continuous moderate exercise) and coaching interventions (psychotherapy, lifestyle counseling) to test the effects on cognitive function. People living with HIV who are stable on HIV antiretroviral therapy (Ages 50+) 2028
Breaking Prolonged Sitting with High-intensity Interval Training to Improve Cognitive and Brain Health in Older Adults TBD Dominika Pindus, University of Illinois Feasibility trial of brief high intensity interval training (HIIT) exercise breaks to interupt sitting and improve cognitive function Healthy, sedentary older adults without dementia (Ages 60 - 75) 2025
Exercise Adherence and Cognitive Decline: Engaging with the Black Community to Develop and Test a Goal Setting and Exercise Intensity Intervention TBD Angela Bryan, University of Colorado Anschutz Medical Campus Moderate to vigorous physical activity intervention with goal setting that aims to target biomarkers associated with cognitive decline Middle aged and older adults (Ages 45+) 2025
Guided Episodic Future Thinking to Increase Physical Activity Adherence and Promote Healthy Brain Aging Among Mid-life Adults TBD Laura Martin, University of Kansas Medical Center The application will develop and refine guided imagery exercise and test whether it increases adherence to exercise among mid-life adults Older adults able to participate in high-intensity interval training (HIIT) exercise (Ages 65 - 85) 2027
Locomotion Adaptation Deficits in Older Adults with Mild Cognitive Impairment and Alzheimer's Disease TBD Trisha Kesar, Emory University Walking intervention to improve cognition and mobility Adults with or without mild cognitive impairment or Alzheimer's disease diagnosis (Ages 50 - 90) 2025
Unraveling the Mechanisms of a Novel Music Intervention for Physical Activity Promotion in Older Adults TBD Jennifer Etnier, University of North Carolina at Greensboro Rhythmic Auditory Stimulation that promotes physical activity behavior change in low-active older adults Older adults (Ages 65+) 2025
Music
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Impact of Music Improvisation Training on Brain Function and Cognition among Older Adults TBD Julene Johnson, University of California San Francisco Music improvisation intervention to promote improvements in self-regulation and facilitate late-life engagement in cognitively challenging activities Neurologically healthy older and younger adults 2026
Neurostimulation
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Adaptive Neuromodulation of Working Memory Networks in Aging and Dementia Neuromodulation of Memory in Aging (TMS-AD) Simon Davis, Duke University Closed-loop transcranial magnetic stimulation (TMS) to establish parameters that can reliably control brain states during normal memory functioning in healthy aging and mild cognitive impairment Healthy older adults and individuals with mild cognitive impairment (Ages 60 - 75) 2027
Gamma-Music Based Intervention for Mild Alzheimer's Disease TBD Psyche Loui, Northeastern University Non-invasive gamma-frequency (40 Hz) light-flickering and auditory tone-stimulation Participants with mild Alzheimer’s disease (Ages 55 - 90) 2027
Individualized Closed-Loop Neuromodulation Therapy for Alzheimer's Disease Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease Joan Camprodon, Massachusetts General Hospital Closed-loop transcranial Alternating Current Stimulation (tACS) at 40 Hz to modulate brain oscillations and cognition, as an individualized and potential disease-modifying precision therapy for Alzheimer's disease Participants with Alzheimer's disease (Ages 50 - 80) 2024
Treating Mild Cognitive Impairment with Transcranial Direct Current Stimulation Stimulation to Improve Memory (STIM) Benjamin Hampstead, University of Michigan Transcranial direct current stimulation (tDCS) to treat mild cognitive impairment People with mild cognitive impairment (Ages 65+) 2024
Treating Mild Cognitive Impairment with Transcranial Direct Current Stimulation STIM+: PET Biomarker Education & Disclosure (STIM+) Benjamin Hampstead, University of Michigan Transcranial direct current stimulation Older adults with mild cognitive impairment 2024
Gamma Induction for Amyloid Clearance in Alzheimer's Disease Gamma Induction for Alzheimer's Disease Emiliano Santarnecchi, Massachusetts General Hospital Transcranial Alternating Current Stimulation (tACS) to induce increase in gamma oscillations, and assess acute and long-lasting changes in Aß and p-tau levels via PET imaging to investigate the clinical, neurophysiological and cognitive impact Adults with mild to moderate Alzheimer's disease (Ages 45+) 2023
Treating Primary Progressive Aphasia And Elucidating Neurodegeneration In the Language Network Using Transcranial Direct Current Stimulation Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS Roy Hamilton, University of Pennsylvania High definition transcranial direct stimulation (tDCS) of the left frontal lobe with the goal of developing a potential treatment for primary progressive aphasia (PPA) Adults with either nonfluent/agrammatic primary progressive aphasia (PPA) or logopenic variant PPA (Ages 45 - 80) 2025
Evaluating the Neurocomputational Mechanisms of Explore-Exploit Decision Making in Older Adults Evaluating the Neurocomputational Mechanisms of Explore-Exploit Decision Making in Older Adults Robert Wilson, University of Arizona Transcranial Magnetic Stimulation (TMS) to vertex, right inferior frontal gyrus, and right frontal pole to explore effects on decision-making Healthy younger adults (Ages 18 - 30) and older adults (Ages 65 - 74), with no subjective memory complaints. 2024
Improving Working Memory in Older Adults by Restoring Large-Scale Cortical Interactions Improving Working Memory in Older Adults Robert Reinhart, Boston University High-definition transcranial alternating-current stimulation of the frontal and temporal cortex, to improve working memory and cognition Younger adults (Ages 18 - 30) and older adults (Ages 68 - 80) 2024
Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease with Near-Infrared Photobiomodulation The Revitalize Study in Older Adults at Risk for Alzheimer's Disease Dawn Bowers, University of Florida Infrared stimulation to assess improvements in cognition function and network connectivity Older adults with subjective cognitive complains and family history of Alzheimer's disease (Ages 65 - 89) 2024
Enhancement of Hippocampal Plasticity Using Repetitive Transcranial Magnetic Stimulation Enhancement of Hippocampal Plasticity Using Repetitive Transcranial Magnetic Stimulation Ying-Hui Chou, University of Arizona Repetitive Transcranial Magnetic Stimulation (rTMS) in hippocampus to determine its therapeutic effect on memory function and brain plasticity People with Amnestic Mild Cognitive Impairment (Ages 50 - 80) 2025
Non-Invasive Home Neurostimulation for Mild to Moderate Alzheimer's Disease: Double-Blind, Sham Controlled Randomized Clinical Trial NeurostImulation for Cognitive Enhancement in Alzheimer's Disease (NICE-AD) Joe Verghese, Albert Einstein College of Medicine Transcranial direct current neurostimulation (tDCS) at home intervention to improve cognitive performance and symptoms in patients with mild to moderate Alzheimer’s Disease People with Alzheimer's disease (Ages 60+) 2025
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Dan Iosifescu, New York University School of Medicine Transcranial Photobiomodulation (t-PBM), which penetrates robustly into the cerebral cortex, stimulating the mitochondrial respiratory chain, and significantly increasing cerebral blood flow, to improve cognitive deficits People with Amnestic Mild Cognitive Impairment (Ages 65 - 85) 2025
Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment Nanthia Suthana, University of California Los Angeles Theta burst transcranial magnetic stimulation, a non-invasive neuromodulation method applied to brain areas that are functionally connected to the hippocampus in order to improve/restore memory function People with Amnestic Mild Cognitive Impairment (Ages 60 - 90) 2025
Transcranial Direct Current Stimulation in Typical and Atypical Alzheimer's Disease Effects of Electrical Stimulation on Verbal Learning in Typical and Atypical Alzheimer's Disease Kyrana Tsapkini, Johns Hopkins Bayview Medical Center Transcranial direct current neurostimulation (tDCS) to improve clinical symptoms of mild cognitive impairment People with probable Alzheimer's disease (Ages 50+) 2025
The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive Performance The Wandering Nerve: Gateway to Boost Alzheimer's Disease Related Cognitive Performance (WALLe) Heidi Jacobs, Massachusetts General Hospital Transcutaneous vagus nerve stimulation (tVNS) to improve cognitive function At-risk older adults (Ages 60 - 85) 2026
Targeting Language-Specific and Executive-Control Networks with Transcranial Direct Current Stimulation in Aphasic AD Targeting Language-specific and Executive-control Networks With Transcranial Direct Current Stimulation in Logopenic Variant PPA Kyrana Tsapkini, Johns Hopkins Bayview Medical Center Transcranial direct current stimulation (tDCS) applied to brain networks that underlie several language-specific vs. executive cognitive functions to maximize the benefits of tDCS in the treatment of neurodegenerative disease Individuals with primary progressive aphasia (Ages 50 - 80) 2027
The Power of 40 Hz Sound/Music for Older Adults with Mild Cognitive Impairment Sound and Music for Mild Cognitive Impairment Junxin Li, Johns Hopkins Bayview Medical Center Feasibility and preliminary efficacy of 40 Hz music (Condition A), 40 Hz sound (Condition B) and preferred music (Condition C) on neural gamma activity and cognitive function in community-dwelling older adults with amnestic mild cognitive impairment Older adults with amnestic MCI (65+ years of age) 2024
Interleaved TMS-fMRI for Hippocampal Stimulation: Modeling Dose-Response Relationship in Amnestic Mild Cognitive Impairment Interleaved TMS-fMRI for Hippocampal Stimulation: Modeling Dose-Response Relationship in Amnestic Mild Cognitive Impairment (TMS-fMRI) Ying-Hui Chou, University of Arizona Spaced Theta burst stimulation (TBS) to improve memory performance and hippocampal function in mild cognitive impairment Individuals with amnestic mild cognitive impairment 2024
Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia (ACDCStim) Alvaro Pascual-Leone, Hebrew SeniorLife and Hebrew Rehabilitation Center Transcranial alternating current stimulation targeting the left angular gyrus (tACS) at gamma frequency and transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex Older adults with mild dementia (Ages 55+) 2027
Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia Kyrana Tsapkini, Johns Hopkins Bayview Medical Center Transcranial direct current stimulation (tDCS) therapy in primary progressive aphasia (PPA) Older adults with primary progressive aphasia (Ages 50 - 80) 2027
Accelerating Cognitive Gains from Digital Meditation with Noninvasive Brain Stimulation: A Pilot Study in MCI TBD David Ziegler, University of California San Francisco Closed-loop digital meditation (MediTrain) and transcranial alternating current stimulation (tACS) to improve cognition and wellbeing in adults with mild cognitive impairment Mild cognitive impairment (Ages 60 - 85) 2025
Modulation of Hippocampal Circuitry and Memory Function with Focused Ultrasound in Amnestic MCI Modulation of Hippocampal Circuitry and Memory Function With Focused Ultrasound in Amnestic MCI (LIFUP-MCI) Susan Bookheimer, University of California Los Angeles Low intensity focused ultrasound pulsation (LIFUP) to improve learning and memory Adults (Ages 75+) 2026
Multimodal Musical Stimulation for Healthy Neurocognitive Aging TBD Psyche Loui, Northeastern University Gamma frequency stimulation is administered via lights, and tuned to user-defined music; participants receive the intervention by listening to music while watching lights Neurologically healthy older and younger adults 2024
Transcranial Magnetic Stimulation for MCI: A Phase II Dose-response Study Transcranial Magnetic Stimulation for MCI (PUSH2) Andreana Benitez, Medical University of South Carolina Intermittent theta-burst repetitive transcranial magnetic stimulation (iTBS-rTMS) to improve cognitive function and depression People with Mild Cognitive Impairment and Major Depressive Disorder (Ages 60 – 85) 2028
Neuromodulation of Brain Network Function in Preclinical and Prodromal Alzheimer's Disease TBD Alexandra Touroutoglou, Massachusetts General Hospital Repetitive transcranial magnetic stimulation (rTMS) to improve brain function and improve symptoms in Alzheimer's disease Amyloid-positive people with and without amnestic mild cognitive impairment (Ages 65 – 85) 2025
Personalized Synchronization of Cortical Rhythms to Improve Memory in Alzheimer's Disease TBD Robert Reinhart, Boston University Personalized non-invasive brain stimulation to improve memory Cognitively healthy older adults, persons with mild cognitive impairment, or persons with Alzheimer's disease (Ages 50 - 100) 2028
Sleep-related
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Light, Metabolic Syndrome and Alzheimer’s Disease: A Non-Pharmacological Approach Light and the Effect on Metabolic Syndrome and Alzheimer's Disease Mariana Figueiro, Icahn School of Medicine at Mount Sinai 8-week Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system Older adults with mild to moderate Alzheimer's Disease diagnosis and Type 2 diabetes (Ages 55+) 2024
Understanding Circadian Responses to Light in Persons with Mild Cognitive Impairment and Alzheimer's Disease Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment Mariana Figueiro, Icahn School of Medicine at Mount Sinai Lighting interventions to suppress melatonin and promote better sleep and cognition Older adults with mild cognitive impairment 2024
A Non-pharmacological Multi-Modal Therapy to Improve Sleep and Cognition and Reduce Mild Cognitive Impairment Risk Enhanced CBTi for Older Adult Sleep and Cognition Daniel Gartenberg, Proactive Life, Inc Internet of Things (IoT) devices, such as the FitBit, Apple Watch, and Oura Ring, to improve sleep and reduce mild cognitive impairment Cognitively healthy older adults (Ages 65+) 2023
Primary Prevention of Alzheimer's Disease: Examining the Effects of Cognitive Behavioral Therapy on Cognitive Function and Amyloid-beta in Older Adults with Symptoms of Insomnia SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid Catherine Siengsukon, University of Kansas Medical Center CBT-I, cognitive behavioral therapy for insomnia People with difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights per week for the past 3 months (Ages 60 - 85) 2024
Personalized OSA Treatment and Effects on AD Biomarkers and Cognition Among Blacks TBD Girardin Jean-Louis, University of Miami School of Medicine Personalized OSA Treatment Adherence Model (PRAISE), a personalized obstructive sleep apnea (OSA) treatment adherence model; participants will be exposed to either personalized OSA videos (intervention arm) or standard online videos (control arm) Older black adults newly diagnosed with obstructive sleep apnea (Ages 60 – 85) 2027
The Long-Term Impact of Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment Mariana Figueiro, Icahn School of Medicine at Mount Sinai Light intervention to improve sleep and mild cognitive impairment People with amnestic mild cognitive impairment or mild Alzheimer's disease (Ages 65+) 2024
The Impact of Sex Hormones on Sleep-Dependent Memory in Young and Midlife Men and Women TBD Fiona Baker and Sara Mednick, SRI International Closed-loop targeted memory reactivation (CL-TMR) uses targeted auditory cueing during the precise phase of the slow oscillation to enhance sleep spindles and boost memory Women (Ages 46 – 54) 2024
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease Atul Malhotra, University of California San Diego Supplemental oxygen and Continuous Positive Airway Pressure (CPAP) machine to determine if oxygen is a viable therapeutic strategy to improve memory Cognitively healthy older adults (Ages 65-85) 2025
Slow-wave Sleep Enhancement in Those At-Risk for Alzheimer's Disease: Links with Memory, Excitotoxicity, and Plasma A-beta Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease (ALPS) Kristine Wilckens, University of Pittsburgh Habitual slow-wave sleep enhancement to improve cognition Older adults (Ages 65 - 85) 2026
The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients with Alzheimer's Disease and Related Dementias (ADRD) Rhythmic Light Therapy for Alzheimer's Disease Patients Mariana Figueiro, Icahn School of Medicine at Mount Sinai Rhythmic Light Therapy to improve sleep and cognition Older adults with mild cognitive impairment 2026
Home Sleep Therapy System for Mild Cognitive Impairment TBD Don Tucker, Brain Electrophysiology Laboratory Company, Llc Neurosom® Electric Sleep Therapy (NEST) system to allow researchers to conduct transcranial electrical stimulation (TES) studies to improve sleep in seniors with mild cognitive impairment Adults with amnestic mild cognitive impairment (Ages 55 - 85) 2023
Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Older Adults with Mild Cognitive Impairment Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND) Meghan Mattos, University of Virginia Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention Older adults with mild cognitive impairment and insomnia (Ages 65+) 2027
Light, Metabolic Syndrome And Alzheimer's Disease: A Non-Pharmacological Approach Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2 Mariana Figueiro, Icahn School of Medicine at Mount Sinai Tailored Lighting Intervention to improve sleep disturbances, inflammation, insulin sensitivity (Si) and glucose disposal (Sg) and cognition in patients with mild cognitive impairment or mild Alzheimer's disease and related dementias (AD/ADRD) and sleep disturbances Adults with Alzheimer's disease and related dementias (AD/ADRD) who live in controlled environments (i.e., assisted living facilities and nursing homes) 2024
Use of 7T Multimodal Imaging to Detect Brain Changes Associated with Light Therapy in Persons with Mild Cognitive Impairment and Mild Alzheimer's Disease 7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD Priti Balchandani, Icahn School of Medicine at Mount Sinai High-resolution multi-modal 7T imaging to investigate the impact of lighting intervention therapy (LIT) on sleep physiology and brain structure, function, and connectivity in people with mild cognitive impairment and mild Alzheimer's disease Amnestic mild cognitive impairment or mild Alzheimer's disease patients with a confirmed Aß+ PET scan 2024
Methodology Issues in a Tailored Light Treatment for Persons with Dementia - Aim 2 Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2 Mariana Figueiro, Icahn School of Medicine at Mount Sinai Light exposure treatment to investigate the effect on sleep, mood, and agitation in persons with Alzheimer's disease or related dementias living in assisted living and nursing home settings Individuals with Alzheimer's disease or related dementias and sleep problems (Ages 65+) 2025
Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) TBD Katie Stone, California Pacific Medical Center (Sutter Health) Obstructive sleep apnea therapies including positive airway pressure, oral appliance therapy, and positional therapy, to promote cognitive function in older adults Cognitively normal older adults with moderate to severe obstructive sleep apnea (Ages 55 - 75) 2028
Social Engagement
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Enhancing Social Engagement through Online Gameplay for Older Adults with and without Mild Cognitive Impairment TBD Dillon Myers, Potluck, LLC OneClick, an online social engagement platform, to benefit health outcomes affected by social engagement (survival, onset of dementia) Adults with mild cognitive impairment 2024
Center for Research and Education on Aging and Technology Enhancement - CREATE: Virtual Reality to Support Cognitive Health and Engagement and Socialization Among Aging Adults Virtual Reality to Support Aging Adults Sara Czaja, Joan and Sanford I Weill Medical College of Cornell University Virtual reality program for social activity and cognitive engagement Community dwelling older adults with mild cognitive impairment 2027
Center for Research and Education on Aging and Technology Enhancement - CREATE: Technology Support for Cognition and Social Engagement for Aging Adults with Mild Cognitive Impairment (MCI) A Software System to Support Aging Adults With A Cognitive Impairment Sara Czaja, Joan and Sanford I Weill Medical College of Cornell University Intelligent Adaptive System, an innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with mild cognitive impairment Cognitively diverse older adults 2027
Stress Reduction/Mindfulness
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Association of Perceived Stress and Cognition PRogram to Improve Stress-levels and Enhance Memory (PRISEM) Ambar Kulshreshtha, Emory University A web-based multidisciplinary stress reduction program to examine the association of stress and cognition, role of cardiovascular disease risk factors, and related health disparities African Americans and White adults with mild cognitive impairment 2025
Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease (Stress-AD) Cynthia Munro, Johns Hopkins Bayview Medical Center Response to an acute stressor (trier social stress test) in mild cognitive impairment Adults with mild cognitive impairment 2027
Optimizing a Closed-loop Digital Intervention for Remediating Cognitive Decline and Reducing Stress in Older Adults TBD David Ziegler, University of California San Francisco MediTrain, a digital meditation intervention to reduce cogntiive decline and emotional stress Older adults 2027
PATH-Pain: A Primary Care-Based Psychosocial Intervention to Improve Cognitive and Depression Outcomes in Older Adults with MCI and Early Stage AD A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD (PATH-Pain) Dimitris Kiosses, Joan and Sanford I Weill Medical College of Cornell University Problem Adaptation Therapy for Pain (PATH-Pain) primary-care based psychosocial intervention designed to reduce stress Adults with mild cognitive impairment or early stage Alzheimer's disease (Ages 60+) 2026
Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients with Co-morbid Heart Failure and Cognitive Impairment Mind Your Heart-II (MYH-II) Elena Salmoirago-Blotcher, Miriam Hospital A mindfulness training intervention to improve cognitive function in patients with co-morbid heart failure and cognitive impairment Individuals with mild cognitive impairment and heart failure 2027
Effects of Acute Stress Exposure on Plasma Beta-Amyloid Levels Acute Alzheimer's Disease Biomarker Responses Mara Mather, University of Southern California Measure the plasma beta-amyloid response to an acute laboratory stressor using the socially evaluated cold pressor test (SECPT) to aid in understanding how stress contributes to Alzheimer's disease development and progression in people Healthy adults (Ages 18-65) 2024
A Pilot Study of the Impact of Personalized Digital Meditation on Improving Cognition and Sleep and Reducing Stress in MCI TBD David Ziegler, University of California San Francisco Closed-loop digital meditation to improve cognitive function, sleep, and stress in older adults Older adults with mild cognitive impairment and cognitively normal older adults (Ages 60 - 85) 2025
Other
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain Ana-Maria Vranceanu, Massachusetts General Hospital Two symptom management programs, Active Brains-Digital (AB-D) and Health Enhancement Program (HEP), to assess how each program may help in improving multimodal physical, cognitive, and emotional function Older adults with nonmalignant chronic pain for more than 3 months and early cognitive decline (Ages 60+) 2027
Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk Michal Schnaider Beeri, Icahn School of Medicine at Mount Sinai Hyperbaric oxygen therapy intervention to improve cognitive function and increase cerebral blood flow and glucose utilization in people with mild cognitive impairment People with mild cognitive impairment and diabetes (Ages 65+) 2024
Long-Term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Study ACHIEVE Brain Health Follow-Up Study (ACHIEVE-BHFU) Frank Lin, Johns Hopkins Bayview Medical Center Follow up of ACHIEVE cohort for an additional three years to determine the long- term effects of hearing intervention (i.e., participants randomized to hearing intervention at Year 0) versus successful aging/delayed hearing intervention control (i.e., participants randomized to successful aging intervention at Year 0 and offered the hearing intervention after their Year 3 visit) on cognitive and brain outcomes Older adults with mild-to-moderate hearing loss and a MMSE score greater than or equal to 23 (Ages 73 - 89) 2027
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD) Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease Sumeet Seth, EvON Medics Computerized Olfactory Training Program (COT), a portable, home-based product to prevent progressive cognitive decline and progressive dementia in early Alzheimer's Disease Adults with diagnosis of probable mild Alzheimer's disease (Ages 65 - 85) 2024
Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults TBD Katie Schenning, Oregon Health and Science University IV vs. inhalational anesthesia on post-operative delirium, post-operative cognitive dysfunction, functional status, and patient-reported outcomes Older adults undergoing elective inpatient non-cardiac surgery (Ages 75+) 2027
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease Richard Holden, Indiana University Digital Brain Safe mobile app to reduce exposure to anticholinergic drugs Adults who have taken at least 1 anticholinergic medication within the past 90 days (Ages 65+) 2024
Reducing Risk of Dementia through De-prescribing (R2D2) Reducing Risk of Dementia Through Deprescribing (R2D2) Noll Campbell, Purdue University Pharmacist-driven de-prescribing protocol focused only on targeted anticholinergic medications Older adults with subjective cognitive dysfunction and at least one order for a strong anticholinergic medication in the previous 12 months (Ages 65+) 2024
Impacts of Receiving Alzheimer's Disease Genetic Risk Information Among Latinos in Northern Manhattan Information About Alzheimer's Disease for Latinos in New York City (IDEAL) Ruth Ottman, Columbia University Information about risk of Alzheimer's disease given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history, to assess the psychosocial and behavioral impacts Latino or Hispanic adults (Ages 40 - 64) 2024
RETAIN: A Digital Therapeutic for Alzheimer's Risk Reduction TBD Mark Mcinnis, RETAIN Health, Inc. Digital therapeutic designed to reduced risk of Alzheimer's disease Normal healthy volunteers with a family history of Alzheimer's disease 2024
Returning Research Results that Indicate Risk of Alzheimer's Disease to Healthy Participants in Longitudinal Studies Returning Research Results That Indicate Risk of Alzheimer's Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE) Sarah Hartz, Washington University in St. Louis Returning research results to participants to measure impact on cognitive and psychosocial outcomes Cognitively normal individuals who have had imaging studies within 18 months, APOE genotyping, and are scheduled for annual visits 2025
Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly: NIA SCORE NeuroCognition After Carotid Recanalization (NIA-SCORE David Hasan, Duke University Endovascular techniques (or hybrid of carotid endarterectomy and endovascular techniques) to improve cognitive outcomes in individuals with complete occlusion of the internal carotid artery (COICA) Adults with complete occlusion of the Internal carotid artery (ICA) due to atherosclerotic disease, a recent history of a transient ischemic attack or stroke, and a MoCA < 26 (Ages 21 - 70) 2024
Enhancing Gamma Band Response to Improve Working Memory in Individuals with Mild Cognitive Impairment Neurofeedback to Improve Working Memory in Mild Cognitive Impairment Fiza Singh, University of California San Diego EEG-neurofeedback (EEG-NFB) computer-based brain training program to improve working memory in individuals with amnestic mild cognitive impairment People with Amnestic Mild Cognitive Impairment (Ages 60 - 85) 2025
Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: A Randomized Clinical Trial Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans With Diabetes and Mild Cognitive Impairment: A Randomized Clinical Trial (DREAM) Barry Rovner, Thomas Jefferson University Diabetes Mellitus-Specific Behavioral Activation (DM-BA) to prevent decline in verbal memory in African American adults with amnestic multiple-domain mild cognitive impairment African-American adults with amnestic mild cognitive impairment and poorly controlled diabetes mellitus (Ages 65+) 2025
Compensation Training and Lifestyle Modifications to Promote Healthy Aging in Persons at Risk for Alzheimer's Disease: A Digital Application Supported Intervention Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention (BB2) Sarah Tomasweski-Farias, University of California Davis Digital Memory Notebook intervention, an interactive application used to facilitate behavioral change and enhanced motivation People with Alzheimer's disease or mild cognitive impairment (Ages 65 - 90) 2025
ADRD Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers Motivating Change in Aging Smoker Adrienne Johnson, University of Wisconsin - Madison Motivation to Quit Intervention to increase motivation to quit, quit attempts, and use of evidence-based smoking treatments (EBSTs) for older adult smokers Older adult smokers (Ages 50 - 80) 2026
Clinical Trial of Vestibular Therapy to Reduce Falls in Patients with Alzheimer's Disease Vestibular Therapy in Alzheimer's Disease Yuri Agrawal, Johns Hopkins Bayview Medical Center Vestibular therapy to reduce falls and improve balance in older adults with mild to moderate Alzheimer's disease and vestibular loss Adults with mild-moderate Alzheimer's disease & vestibular loss (Ages 60+) 2026
Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging Natalie Ebner, University of Florida Neurofeedback training using real time fMRI to increase activity in the anterior cingulate gyrus to improve learning Healthy older adults (Ages 60 - 85) 2027
Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment IHT for Mild Cognitive Impairment Xiangrong Shi, University of North Texas Health Science Center An intermittent-hypoxia training (IHT) program to prevent or reverse cognitive decline and neurodegeneration in mild cognitive impairment Individuals with amnestic mild cognitive impairment 2025
Mediators and Moderators of Auditory Training TBD Aaron Seitz, Northeastern University An auditory training intervention to mitigate hearing issues that promote dementia risk Older adults (ages 60 - 85) with no more than typical hearing loss for their age, no evidence of dementia and comparison younger adults (ages 18 - 30) with normal hearing 2027
Center for Research and Education on Aging and Technology Enhancement - CREATE: Technology Tools for Cognitive Support for Health Management Activities for Aging Adults With and Without Mild Cognitive Impairment Digital Tools to Support Healthcare Decision Making Sara Czaja, Joan and Sanford I Weill Medical College of Cornell University Intelligent Decision Support Tool, an innovative intelligent decision tool for health decisions aims at providing health management support for older adults with and without mild cognitive impairment Cognitively diverse older adults 2027
My Healthy Brain: A Mindfulness-Based Lifestyle Intervention to Modify Early Risk of Dementia in Older Adults Brain Health Program for Older Adults With Subjective Cognitive Decline Ryan Mace, Massachusetts General Hospital My Healthy Brain (MHB) teaches education, mindfulness skills, and behavior change principles. All MHB skills were adapted to account for commonly reported Subjective Cognitive Decline symptoms (e.g., forgetfulness) and co-morbid psychological barriers (e.g., low motivation) that can interfere with lifestyle behavior change. Medical providers and older adults at risk for Alzheimer's disease and related dementia (Ages 60+) 2027
Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementia TBD Justin Golub, Columbia University Hearing aids to prevent cognitive decline in those at risk for Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) Older adults with early-stage age-related hearing loss (ARHL) and amnestic mild cognitive impairment (55 - 75 years of age) 2027
Effects of Resonance-Frequency Breathing on Preclinical Alzheimer’s Disease Biomarkers and Cognition TBD Mara Mather, University of Southern California Ten weeks of daily paced breathing sessions to determine whether resonance breathing improves plasma Alzheimer's disease (AD) biomarkers, identify how resonance-frequency breathing affects plasma AD biomarkers, assess whether daily resonance-frequency breathing accelerates consolidation of new learning, and compare effects in African Americans vs. European Americans Cognitively normal African-American and European-American adults (Ages 50 - 70) 2028
Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment TBD Patrick Smith, University of North Carolina at Chapel Hill Time restricted fasting intervention to improve metabolic and cognitive health Amnestic mild cognitive impairment (Ages 65 - 80) 2025
Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline Remote Monitoring and Virtual Collaborative Care For Hypertension Control to Prevent Cognitive Decline Phase II (vCCC 2) Jeffrey Burns, University of Kansas Medical Center Remote blood pressure monitoring and management through a virtual Collaborative Care Clinic (vCCC) Older adults with hypertension 2025
Bilingual Factors Associated with Cognitive Reserve and Linguistic Resilience in Hispanics with Primary Progressive Aphasia Bilingual Factors Associated with Cognitive Reserve and Linguistic Resilience in Hispanics with Primary Progressive Aphasia Stephanie Grasso, University of Texas at Austin Naming intervention for individuals with logopenic or semantic variant primary progressive aphasia (PPA) or script training intervention for individuals with nonfluent/agrammatic PPA Bilingual individuals with PPA 2027
The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients with Alzheimer's Disease and Related Dementias (ADRD) Phase 2 - Rhythmic Light Therapy for Alzheimer’s Disease Mariana Figueiro, Icahn School of Medicine at Mount Sinai Gamma oscillation entrainment for persons with amnestic mild cognitive impairment or mild Alzheimer's disease to improve sleep and cognition People with amnestic mild cognitive impairment or mild Alzheimer's disease (Ages 55+) 2026
Attentional Mechanisms of Cognitive Compensation in Subjective Cognitive Decline and AD Risk Attentional Mechanisms in SCD (AMoCC-SCD) Kimberly Albert, Vanderbilt University Medical Center Mecamylamine, a centrally and peripherally active non-competitive antagonist of acetylcholine at C6 (ganglionic) type nicotinic receptors, to better identify older adults at risk for Alzheimer’s Disease Community-dwelling Chinese American older adults (Ages 55+) 2028
Time Restricted Eating for Prevention of Age-Related Vascular Cognitive Decline in Older Adults The Effect of Intermittent Fasting on Brain Health Andriy Yabluchanskiy, University of Oklahoma Time restricted eating intervention to improve neurovascular function and cognitive performance Older adults (Ages 55 - 80) 2025
Feasibility of Improving Glycemia to Prevent Alzheimer's Disease TBD Jill Morris, University of Kansas Medical Center Heat therapy to improve systemic blood glucose metabolism to reduce risk for Alzheimer's disease Cognitively healthy people (Ages 65+) 2028

Section 4: Dementia Care and Caregiver

Advance Directives/Care Planning
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Preparation for End of Life Decision Making in Mild Alzheimer's Disease Two-Phased Study of SPIRIT in Mild Dementia Mi-Kyung Song Emory University SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a patient- and family-centered advanced care planning (ACP) intervention based on the Representational Approach to Patient Education to promote cognitive and emotional preparation for end-of-life decision making Patient (mild Alzheimer's disease)-surrogate dyads (Ages 18+) 2024
Pragmatic Trial to Improve Communication for Primary Care Patients with ADRD Improving Communication for Primary Care Patients Jennifer Wolff, Johns Hopkins Bayview Medical Center SHARING Choices (Sharing access to Health records, Agenda setting and RespectING Choices to Engage Families), a multicomponent communication intervention that seeks to proactively engage family members and support advance care planning (ACP) in primary care Adults with Alzheimer's disease and related dementias (AD/ADRD) (Ages 65+) 2024
POST Facilitation for Community Dwelling Older Adults with and without Dementia POST Facilitation for Community Dwelling Older Adults (POST-RCT) Alexia Torke, Indiana University-Purdue University Indianapolis Physician Orders for Scope of Treatment (POST), a virtual at-home advanced care planning (ACP) intervention to make decisions about care goals and to record preferences in writing Frail, older community dwelling adults (Ages 65+) and their surrogate decision maker 2024
Involving Family to Improve Advance Care Planning for Primary Care Patients with ADRD SHARE: Sharing Healthcare Wishes in Primary Care Jennifer Wolff, Johns Hopkins Bayview Medical Center Sharing Healthcare Wishes in Primary Care (SHARE), a multicomponent communication intervention to proactively engage family members or friends to support advance care planning in primary care Persons with cognitive impairment (Ages 80+) and family dyads 2024
Decision Making and Implementation of Aging-in-Place/Long Term Care Plans among Older Adults Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults Lee Lindquist, Northwestern University Plan Your Lifespan, a web-based decision-making and planning tool to examine the mediating/moderating factors involved in decision-making, timing of decision implementation, and goal concordance for older adults aging-in-place/long term care Community-dwelling older adults (Ages 55+) 2024
Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits Intervention in Primary Care for Older Adults with and without Alzheimer's Dementia Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease (ENACT) Hillary Lum, University of Colorado Anschutz Medical Campus ENgaging in Advance Care planning Talks (ENACT) Group Visits intervention to increase advance care planning (ACP) documentation among older adults in primary care settings, including older adults with cognitive impairment Older adults that have at least one primary care clinic visit in the past 12 months (Ages 70+) 2026
Implementation Strategies to Promote Advance Care Planning among Persons Living with ADRD and Those with Mild Cognitive Impairment in Outpatient Primary Care Practices TBD Jennifer Gabbard, Wake Forest University ACPdSmart is a dementia-specific portal-based tool for advance care planning engagement Adults with recognized or probable mild cognitive impairment or mild dementia, yet retain decisional capacity to complete advance care planning (Ages 65+) 2027
Hybrid Efficacy/Effectiveness Trial to Promote Goals-of-Care Discussions for Patients with Alzheimer's Disease and Related Dementias and their Family Caregivers Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers (PICSI-M) Erin Kross, University of Washington "Jumpstart", a one-page guide using patient-specific information to prompt and guide clinicians in goals-of-care discussions Adults with an ICD10 code for Alzheimer's disease and related dementias (AD/ADRD) in the electronic health record (EHR) in the prior two years (Ages 55+) 2027
Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive Advance Care Planning with Videos for the Elderly and all Patients with Dementia Palliative Care Educator (VIDEO-PCE) Michael Paasche-Orlow, Tufts Medical Center COVID-19 advance care planning (ACP) Educator-led, video-assisted palliative care intervention to improve patient-clinician communication, increase ACP documentation, and lead to more patient-centered care at the end of life Hospitalized patients and any patient with Alzheimer's disease and related dementias, as well as proxy decision-makers (Ages 65+) 2024
Caregiver Assessments, Tools, Training, and Education
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
The PorchLight Project The PorchLight Project Joseph Gaugler, University of Minnesota Twin Cities The Porchlight Project is multicomponent training delivered to volunteers and includes three established online training modules on person-centered dementia care; a four-session online training program that demonstrates to volunteers how to apply person-centered dementia care knowledge to their interactions with persons with dementia and their caregivers; and ongoing monthly coaching sessions Family caregivers, persons with dementia, and senior volunteers 2027
Developing a Distance Education System to Train Savvy Caregiver Program Interventionists: Extending Access and Capacity in Community-Based Delivery of Evidence-Based Interventions Savvy System Project Ken Hepburn, Emory University Web-based system to train interventionists on Savvy Caregiver, a dementia family caregiver psychoeducation program Dementia family caregivers (Ages 18+) 2023
Developing a Screening Protocol for Family Caregivers of Older Persons with and without Dementia Seen in Primary Care Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study Catherine Riffin, Joan and Sanford I Weill Medical College of Cornell University Caregiver screening-referral protocol for family caregivers who accompany older adults to their primary care visits Patient-caregiver dyads and healthcare providers 2024
The Caregiver Resource Room: Enhancing Support for Caregivers of Alzheimer's Disease and Related Dementias (ADRD) TBD Francesca Falzarano, University of Southern California Online self-assessment and tailored referral platform to support caregivers of individuals with Alzheimer's disease and related dementia Caregivers of individuals with Alzheimer's disease and related dementia 2026
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals with Alzheimer's Disease and Related Dementias Rural Dementia Caregiver Project Veronica Yank, University of California, San Francisco Building Better Caregivers, an online, self-management and skills building intervention to support isolated dementia caregivers in rural areas Rural dementia caregivers (Ages 18+) 2024
GamePlan4Care: Web-based Delivery System for REACH II GamePlan4Care: Online Support for Family Caregivers (GP4C) Alan Stevens, Baylor Research Institute GamePlan4Care (GP4C), an internet-based system designed to provide immediate, tailored education and skills training to caregivers Caregivers of veterans with Alzheimer's disease and related dementias (AD/ADRD) admitted to the inpatient general medicine service at MEDVAMC 2024
GamePlan4Care: Web-based Delivery System for REACH II TBD Alan Stevens, Baylor Research Institute Hospital GamePlan4Care (GP4C), an internet-based system designed to provide immediate, tailored education and skills training to caregivers in a hospital setting Dementia caregivers in a hospital setting (Ages 18+) 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Primary Progressive Aphasia (PPA) Tele-Savvy (Pilot) PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA Darby Morhardt, Northwestern University Psychoeducational program for caregivers of persons with primary progressive aphasia Caregivers of persons living with a documented diagnosis of primary progressive aphasia (PPA) 2024
Efficacy of the WeCareAdvisor: An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons with Dementia WeCareAdvisor Study for Caregivers of People Living With Dementia Laura Gitlin, Drexel University WeCareAdvisor, an online tool to help caregivers manage behvioral and psychological symptoms in persons with dementia Caregivers (Ages 21+) 2024
Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers (EnACT) Jacqueline Eaton, University of Utah Enhancing Active Caregiver Training intervention to manage common behavioral symptoms associated with Alzheimer's disease and related dementias Caregivers of persons living with Alzheimer's disease and related dementias 2025
Impact of Adult Day Services on Psychosocial and Physiological Measures of Stress Among African American Dementia Family Caregivers TBD Lauren Parker, Johns Hopkins Bayview Medical Center Mechanism study to identify how adult day services influences caregiving related stressors and needs for African American caregivers of individuals with Alzheimer's disease and related dementias African American Caregivers 2025
Using Technology to Support Care Partners for Persons with Alzheimer's Disease: Tele-STELLA Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA (Tele-STELLA) Allison Lindauer, Oregon Health and Science University Telehealth intervention using education and peer support to reduce stress and behavioral symptoms for family care partners for those with Alzheimer's disease and related dementias Rural, African American, and White care partners for those living with Alzheimer's disease and related dementias 2026
Testing Dementia Caregiver TeleCoaching to Reduce Episodes of Abuse and Neglect by Recognizing and Managing Care-Resistant Behaviors Coaching Dementia Caregivers to Master Care-Resistant Behavior (CuRB-IT) Rita Jablonski, University of Alabama at Birmingham Care-Resistant Behavior Internet Training (CuRB-IT) to enhance coping skills of family caregivers and reduce elder abuse and neglect (EAN) Caregivers for persons with Alzheimer's disease and related dementias (AD/ADRD) 2026
An Assistive-Technology Based Caregiver Training Program (CTP) to Enhance Caregiver Effectiveness, Well-being, and Quality of Life, Which Will Improve Overall Care for Individuals Living with AD/ADRD Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes Matthew Golden, MapHabit, Inc. MapHabit System and Caregiver Training Program (CTP) to improve caregiver quality of life and overall patient care Dyads, caregivers and individuals living with dementia 2025
Emergency Preparedness and Support of Caregivers of Persons with Dementia: The Disaster PrepWise Study Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise (DPW-Caregiver) Sato Ashida, University of Iowa Disaster PrepWise (DPW), an intervention program to enhance emergency preparedness and support networks to increase caregiver resilience and minimize distress Caregivers of individuals with Alzheimer's disease and related dementias (AD/ADRD) 2027
Learning Skills Together: A Randomized Controlled Trial of a Complex Care Skills Intervention to Improve AD/ADRD Caregiver Self-Efficacy TBD Kylie Meyer, Case Western Reserve University Learning Skills Together (LST), a complex care skills intervention to improve caregiver self-efficacy Caregivers to persons living with mid-stage Alzheimer's disease and related dementia (AD/ADRD) 2027
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia (Pilot) VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia Annie Chen and Oleg Zaslavsky, University of Washington Virtual Online Communities for Aging Life Experiences (VOCALE), an 8-week online intervention that uses a web-based discussion platform and involves moderation, peer-to-peer support, didactic training, and problem-solving skill enactment Family caregivers (Ages 18+) of persons with Lewy Body Dementia 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Study of the Aliviado DSD Caregiving Mastery Program (Pilot) Study of the Aliviado DSD Caregiving Mastery Program Shih-Yin Lin, New York University Aliviado DSD Caregiving Mastery Program includes Family-centered training on delirium superimposed dementia (DSD) plus an mHealth app-based care plan of DSD prevention, detection, and management tasks and tailored mobile push notification task reminders and encouragements Family caregivers for individuals living with Alzheimer's disease and related dementias (AD/ADRD) 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: The Couple in Control (Pilot) The Couple in Control Lindsay Prizer, Emory University Couple in Control (CiC), a toolkit of communication skills and decisional strategies to help couples experiencing mild cognitive impairment cope with various challenges Dyads of individuals diagnosed with mild cognitive impairment and their care partners 2024
The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons with ADRD TBD Catherine Riffin, Joan and Sanford I Weill Medical College of Cornell University Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias to provide training in observational pain assessment and coaching in effective pain communication techniques Patients with moderate/severe Alzheimer's disease and related dementia and their caregivers 2028
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: WECARE (WellnessEnhancement for Caregivers) (Pilot) WECARE (WellnessEnhancement for Caregivers) Alicia Hong, Emory University Wellness Enhance for Caregivers (WECARE) is a 7-week social media-based behavioral intervention designed for Chinese American family caregivers of persons with Alzheimer’s disease and related dementias Chinese American family caregivers of persons with dementia 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: An AI-Embedded Intervention to Promote Financial Wellbeing Among Latino Family Caregivers (Pilot) TBD Kylie Meyer, Case Western Reserve University An AI-Embedded Intervention that increases caregiver resourcefulness and displaces out-of-pocket caregiving costs with community and other resources to help mitigate financial strain Adult Latino/Hispanic family caregivers to persons living with dementia (Ages 18+) 2024
Rochester Roybal Center for Social Ties and Aging Research: TLC for Latino Caregivers (Pilot) TBD Kathi Heffner, University of Rochester Latino Caregiver Thrive, Learn & Connect (TLC) is a Spanish telehealth caregiver educational and skill-building program to improve caregiver experience Latino caregivers (Ages 45+) 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Improving Care through Improv: Promoting Mastery in the Moment (Pilot) TBD Candace Kemp, Emory University The intervention, “Improving Care though Improv,” involves four highly interactive weekly two-hour sessions delivered over a one-month designed to build care partner skills and improve mastery and care experiences and outcomes Care partners of persons living with dementia 2024
Caregiver as Navigator-Developing Skills Online (CAN-DO): Developing Dementia Family Caregiver Mastery for Navigating Complex Health, Social Service, Legal, Financial, and Family Systems TBD Carolyn Clevenger, Emory University Psychoeducation program that seeks to enhance caregivers’ knowledge, skills and mastery of the many tasks they perform and responsibilities they assume in assisting the person living with dementia Individuals serving as caregivers for family members and friends living with Alzheimer’s disease and related dementias 2028
PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education TBD Jori Fleisher, Rush University Medical Center A caregiver education and peer mentor program comprised of discussion and coaching through specific Lewy Body Dementia knowledge and social support topics Lewy Body Dementia family caregivers 2028
Reducing Burden in Care Partners of Community-Dwelling Persons with Dementia and Oropharyngeal Dysphagia TBD Liron Sinvani, Feinstein Institutes for Medical Research A comprehensive repository for Oropharyngeal Dysphagia related information for care partners of persons with Alzheimer’s disease and AD-related dementias and Oropharyngeal Dysphagia Care partners of hospitalized patients with Alzheimer’s disease and related dementias and Oropharyngeal Dysphagia (Ages 65+) 2025
Family-Based Interventions
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Creating a Faith-Based Toolbox for African Americans Living with Moderate and Severe Dementia Faith-Based Toolbox for African Americans With Dementia Fayron Epps, Emory University Faith-based home activity toolkit (Faith-HAT), meaningful religious and spiritual activities for persons living with dementia to engage in at home with their family caregiver Dyads of persons living with dementia and caregiver (Ages 18+) 2024
STAR Caregivers - Virtual Training and Follow-up STAR Caregivers - Virtual Training and Follow-up (STAR-C-VTF) Robert Penfold, Kaiser Foundation Hospitals - Washington STAR Virtual Training and Follow-up (STAR- VTF), a training using web-based Electronic Health Record portal to help in expand access to and delivery of empirically supported behavioral health services for caregivers and people with dementia Dyads of people with dementia (Ages 55+) and their caregiver 2024
A Training and Fidelity Model to Move and Scale Evidence-based Dementia Care and Caregiver Support Programs into Practice: The Case for COPE in PACE service settings Care of Persons With Dementia in Their Environments (COPE) in Programs of All-Inclusive Care of the Elderly (PACE) Nancy Hodgson, University of Pennsylvania Care of Persons in the Environments (COPE), an online training program for caregivers and care staff of persons with dementia to improve care for persons with dementia Dyads from PACE sites (Ages 21 - 100) 2024
Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons with Dementia and their Care-Partners Early after Diagnosis TBD Sarah Bannon, Icahn School of Medicine at Mount Sinai Resilient Together for Dementia (RT-D), a live video dyadic resiliency intervention Persons Living With Dementia, and Spousal Partner (SP) dyads, along with staff employed at MGH Department of Neurology 2027
Development and Pilot Testing of a Behavioral Economics Mobile Health Digital Tool to Improve Adherence to Non-Pharmacologic Strategies for Behavioral and Psychological Symptoms of Dementia TBD Hayley Belli, New York University School of Medicine Behavioral economics mobile health (BE-mHealth) digital tool that will incorporate BE nudges into 2-3 evidence-based non-pharmacologic strategies for managing behavioral and psychological symptoms of dementia (BPSD) Persons living with dementia and their primary care partners 2027
Improving Caregiver Health and Well-Being
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Mindfulness Based Stress Reduction for Family Caregivers of Dementia Improving Well-Being for Older Adult Family Dementia Caregivers Kathi Heffner, University of Rochester Mindfulness Based Stress Reduction (MBSR) and the Living Well program to see if the programs might be associated with better immune function (response to current influenza vaccine), physical and emotional health, and well-being for family caregivers Adults who currently live with and are the primary caregivers for a community dwelling dementia patient (Ages 60+) 2023
The Caregiver Outcomes of Alzheimer's Disease Screening (COADS) Trial Caregiver Outcomes of Alzheimer's Disease Screening (COADS) Nicole Fowler, Indiana University-Purdue University Indianapolis An early screening intervention involving sending letters to dyads and the primary care physician informing them of the results of the screening of Alzheimer's disease for earlier diagnosis Dyads of older adults (Ages 65+) and family members (Ages 21+) 2024
The Mindful and Self-Compassionate Care Program (MASC): Reducing Stress for Caregivers of Persons with Dementia - Aim 2 MASC: Reducing Stress for Caregivers (MASC) - AIM 2 Christine Ritchie, Massachusetts General Hospital

A randomized control trial with two arms: 1. The Intervention arm (MASC): Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer disease and related dementias (AD/ADRD) manage stress associated with the general caregiver experience; MASC is delivered by a social worker with expertise working with AD/ADRD caregivers and content includes education around stress and caregiving, educational information on strategies to manage stress including exercise, sleep, and social support 2. Control arm (HEP): will receive HEP which is time-, dose-, and attention-matched to MASC however this program will not include any skills.

Caregivers of persons living with dementia 2025
To Reduce the Burden of Caregiving on Health Outcomes of Midlife Women: Asian American Family Caregivers of Persons Living with Alzheimer's Disease Technology-based Information and Coaching Program Tailored for Asian American Midlife Women Who Are Family Caregivers of Persons With Alzheimer's Disease (TACAD) Eun-Ok Im, Emory University The intervention is BC-Care (BrainCheck), a cognitive care planning tool that integrates patient, provider, and caregiver input to generate personalized Alzheimer's disease and related dementias (AD/ADRD) recommendations and follow-up care to be implemented during an AD/ADRD's patient's medical visit Asian American women who are family caregivers of persons living with Alzheimer’s disease, and experts in gerontology/geriatrics 2024
LEAF 2.0: Randomized trial of a technology-based positive emotion intervention for informal caregivers of individuals with Alzheimer's disease Life Enhancing Activities for Family Caregivers (LEAF 2.0) Judith Moskowitz, Northwestern University LEAF, Life Enhancing Activities technology-based intervention to reduce burden and increase well-being for family caregivers of persons living with Alzheimer's disease or related dementias Caregivers (Ages 34 - 87) 2024
Mobile, Web-based Behavioral Intervention for Improving Caregiver Well-being Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being Brent Mausbach, University of California San Diego Mobile Pleasant Events Program (mPEP), a Behavioral Activation Therapy program to increase caregiver's engagement in pleasant activities Dementia caregivers (Ages 40 - 90) 2024
Virtual Coaching to Maximize Dementia Caregivers Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use (TLC) Rebecca Utz, University of Utah Time for Living & Caring (TLC), an online, self-administered intervention to provide informal family caregivers with resources, support, and education to improve their respite time-use (respite is defined as planned time away from caregiving Caregivers (Ages 18+) 2024
Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals with Alzheimer's Disease Mindfulness-based Cognitive Coping for ADRD Caregivers Bruno Kajiyama, Photozig, Inc. Caring Mind App, a mindfulness-based Cognitive Coping intervention to reduce caregiver stress and depressive symptoms Caregivers of individuals living with Alzheimer's disease and related dementia (AD/ADRD) 2023
Midwest Roybal Center for Health Promotion and Translation: OCEAN: Optimizing Cognition via Exercise and Nutrition (Pilot) Optimizing Cognition Via Exercise and Nutrition (OCEAN) Susan Aguinaga, University of Illinois at Chicago A Latin dance program (BAILAMOS™) and Mediterranean diet (MIND) to improve cognitive function Older Latino adults (Ages 50+) 2024
Rochester Roybal Center for Social Ties and Aging Research: Social-Life Enhancing Activities for Caregivers (Pilot) Social-Life Enhancing Activities for Caregivers Benzi Kluger, University of Rochester Social LEAF (Life Enhancing Activities for Family Caregivers), a group video-conference intervention to teach caregivers coping skills to improve social relationships and social connection Caregivers of community-dwelling family member with dementia with Lewy Bodies (DLB) 2024
Rochester Roybal Center for Social Ties and Aging Research: Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers (Pilot) Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers Lee Kehoe, University of Rochester Life Review therapy, a behavioral intervention to address social connection in caregivers by focusing on the caregiving relationship Caregivers and care receiver with mild cognitive impairment and advanced cancer (Ages 50+) 2024
Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals with Alzheimer's Disease and Other Dementias Caregiver Speaks: A Technologically Mediated Storytelling Intervention Debra Parker Oliver, Washington University in St. Louis Caregiver Speakers, a technologically-mediated storytelling intervention using photos to illustrate various feelings and meanings Adult hospice family caregivers of person's living with dementia (Ages 18 - 120) 2024
Using X to Enhance the Social Support of Hispanic and Black Dementia Caregivers (Tweet-SS) X Based Social Support for Hispanic and Black Dementia Caregivers (Tweet-S2) Sunmoo Yoon, Columbia University Health Sciences X-based intervention to enhance the social support (informational, instrumental, emotional, appraisal) for Hispanic and Black dementia caregivers Black or Hispanic dementia caregivers (Ages 18+) 2024
Advancing Alzheimer’s Family Caregiving Interventions and Research Capacity in Vietnam A Multidomain Intervention Program for Older People With Dementia Walter Hinton, University of California Davis Multidomain intervention program that includes physical and cognitive exercises led by physiotherapists and management of metabolic and vascular risk factors by a cardiologist to address cognitive decline, quality of life, and functional ability Individuals living in the community who have a diagnosis of mild-moderate vascular dementia (Ages 60+) 2024
Supplement-Advancing Alzheimer's Family Caregiving Interventions and Research Capacity in Vietnam A Phone Intervention for Family Dementia Caregivers in Vietnam Walter Hinton, University of California Davis Adapted (i.e., Distant REACH VN) intervention training protocol for distance delivery to provide support for family caregivers of people living with dementia Caregiver-care recipient dyads and other staff 2024
Advancing Alzheimer’s Family Caregiving Interventions and Research Capacity in Vietnam Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam Walter Hinton, University of California Davis Vietnam Resources for Enhancing Alzheimer’s Caregiver’s Health (REACH VN), a culturally adapted behavioral intervention to support family caregivers of persons with dementia in Vietnam Family caregivers (Ages 18+) 2024
Advancing Alzheimer’s Family Caregiving Interventions and Research Capacity in Vietnam Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease Walter Hinton, University of California Davis Paper-based cognitive training Vietnamese patients with early Alzheimer's disease and their caregivers 2024
Advancing Alzheimer’s Family Caregiving Interventions and Research Capacity in Vietnam Evaluating the Feasibility of a Mobile Phone-based Intervention on Depression, Anxiety, and Stress of the Dementia Patients' Caregivers Walter Hinton, University of California Davis Information including knowledge and skills related to dementia patient care administered to the participants via a smartphone app (Zalo app) Primary caregivers of patients with dementia 2024
CommunityRx-Dementia CommunityRx-Dementia (CRx-D) Stacy Lindau, University of Chicago Community Rx-Caregiver Resources, tailored resources addressing health-related social needs (HRSN) for caregivers Alzheimer's disease and related dementias caregivers (Ages 18+) 2024
Fostering Caregiver Connections via Intentional Technology Pairing for Caregivers of Patients with Alzheimer's Disease and Other Types of Dementia A Study of Caregiver Connections Via Technology in Dementia Matthew Knutson, Minnesota HealthSolutions Corporation Algorithm to connect caregivers of people with dementia to each other for emotional support Caregivers of persons living with dementia, such as Alzheimer’s disease, Lewy Body dementia and Frontotemporal degeneration 2024
Culturally Responsive Support Programming for Black Caregivers of Persons with Dementia Culturally Responsive Caregiver Support Sheria Robinson-Lane, University of Michigan Culturally tailored support intervention for African American caregivers of persons living with dementia to reduce health disparities African American caregivers of a person living with dementia (Ages 55+) 2025
Mobile App Delivered Mentalizing Imagery Therapy to Augment Remote Family Dementia Caregiver Skills Training Mobile App Psychological Interventions for Family Dementia Caregivers Felipe Jain, Massachusetts General Hospital Guided imagery and mindfulness therapy delivered via mobile app to augment dementia caregiver skills training Primary caregivers (ages 60+) for a relative with Alzheimer's disease and related dementias (AD/ADRD) that uses a smartphone at least 5 days/week 2025
A Home-based, Culturally and Language Specific Intervention for Dementia Family Caregivers: Stress Reduction and Education with Wearable Technology for Health Dementia Family Caregiver Study Jung-Ah Lee, University of California Irvine Stress reduction and dementia education intervention with wearable technology to measure behavioral and physiological measures Adult family caregivers of persons living with dementia 2025
Web-based CBT for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers (NiteCAPP) Christina Mccrae, University of South Florida NiteCAPP, a web cognitive behavioral treatment for insomnia (CBT-I) for rural dementia caregivers to improve caregiver health, mood, burden and cognition Rural dementia caregivers and persons living with dementia 2026
Supporting Family Caregivers of Persons with Dementia Supporting Family Caregivers of Persons With Dementia (ENCODE) George Demiris, University of Pennsylvania ENCODE (Empowering Caregivers of Patients with Dementia) is a behavioral intervention to support family caregivers in pain management for their hospice patients based on the transcriptional theory of stress and coping Caregivers of hospice patients with Alzheimer's disease and related dementias (AD/ADRD) 2026
Addressing the Double Jeopardy of Stress and Hypertension Among African American Female Caregivers of Persons Living with Alzheimer's Disease and Related Dementias Stress and Hypertension in Dementia Caregivers (MIM-DASH) Kathy Wright, Ohio State University Mindfulness in Motion (MIM) plus the Dietary Approaches to Stop Hypertension (DASH) interventions to improve caregiver stress and quality of life African American female caregivers with hypertension (Ages 40+) 2024
Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons with Alzheimer's Disease TBD Bryan Denny, Rice University A smartphone-based cognitive emotion regulation training to improve caregiver health and well-being Caregivers of individuals with Alzheimer's disease and related dementia (AD/ADRD) 2027
Caring4Caregivers: A Theory-driven Mobile Solution to Promote Self-care and Well-being Among Caregivers of Individuals with Alzheimer’s and Related Dementias TBD Kerry Evers, Pro-Change Behavior Systems, Inc. Caring4Caregivers (C4C), a theory-driven mobile solution to promote self-care and well-being among caregivers Caregivers for individuals living with Alzheimer's disease and related dementia (AD/ADRD) 2024
Increasing Meaning to Reduce Loneliness in Care Partners of Persons with AD/ADRD Reduce Loneliness in Care Partners of Persons With AD/ADRD Allison Marziliano, Feinstein Institutes for Medical Research RELOAD-C, an intervention leveraging concepts from Meaning-Centered Psychotherapy to reduce loneliness Individuals with Alzheimer's disease and related dementias (AD/ADRD) and their care partners 2027
Midwest Roybal Center for Health Promotion and Translation: Time Restricted Eating Plus Exercise for Weight Management (Pilot) Time Restricted Eating Plus Exercise for Weight Management Kelsey Gabel, University of Illinois at Chicago An intermittent fasting intervention (time restricted eating, TRE), which involves confining the eating window to 8-10 hours and fasting for the remaining hours of the day, in combination with either resistance training (TRE-RT) or aerobic training (TRE-AT) to examine the effects on body weight, body composition, metabolic disease risk, and cognition in overweight and pre-diabetic adults Adults who are overweight/obese and pre-diabetic (Ages 50 - 85) 2024
Midwest Roybal Center for Health Promotion and Translation: Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis (Pilot) Promoting Physical Activity at a Memory & Aging Clinic Naoko Muramatsu, University of Illinois Chicago Pro-Home MeC, a 12-week in-home physical activity (PA) program, delivered using an app on a tablet hat has built-in motivational enhancement (e.g., music), that consists of: motivational enhancement components, including initial PA discussion between the patient and the memory care clinician, and goal setting with the interventionist; 5 moves for aerobics, strength, flexibility, and balance exercises that target daily functions Adults diagnosed with mild cognitive impairment or mild dementia (Ages 50+) 2024
Rochester Roybal Center for Social Ties and Aging Research: The M&M Study (Pilot) The M&M Study Kathi Heffner, University of Rochester Social Engage Coaching (S-ENG), a behavioral intervention that involves one-on-one coaching with a care manager to increase social engagement and reduce loneliness Caregivers for individuals living with Alzheimer's disease and related dementia (AD/ADRD) 2024
Writing to Heal: Developing an Internet-Based Cognitive-Behavioral Writing Intervention for Alzheimer’s Disease Spousal Caregivers TBD Angie Leroy, Baylor University An internet-based cognitive-behavioral writing intervention to improve caregiver health and well-being Spousal caregivers for individuals living with Alzheimer's disease and related dementia (AD/ADRD) 2027
Developing a Culturally Immersive Psychoeducational Intervention for Black Immigrant Older Adults with Dementia and Their Caregivers: The Black Immigrant Project TBD Manka Nkimbeng, University of Minnesota Twin Cities The proposed intervention is The Active Caregiving Empowering Skills (ACES) intervention which is a psychoeducational program that is based on Cognitive Behavioral Therapy (CBT) to decrease caregiver stress and decrease behavioral distress in persons living with dementia Black older adult immigrants (ages 50+) living with dementia and their informal caregivers 2027
I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer's-Related Symptoms for Caregivers and Patients I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms (I-CARE 2) Richard Holden, Indiana University Brain CareNotes app, a mobile telehealth app used by informal caregivers for behavioral and psychological symptoms of dementia (BPSD) management Informal caregivers of people living with Alzheimer's disease and related dementias (AD/ADRD), and the care-recipients 2027
Using Mobile Technology to Reduce Stress in Caregivers of Persons with Dementia. A Scalable Solution to A Growing Problem STRIDE: Stress Reduction in Dementia Caregivers Ana-Maria Vranceanu, Massachusetts General Hospital "CALM ", a smartphone-based meditation app that teaches users the basics of mindfulness and how to integrate it into daily life to promote sustained practice and provides 10- to 12-minute guided meditations with embedded behavioral principles [e.g., reminders] to facilitate adherence Older adults with with chronic pain comorbid with early cognitive decline (Ages 60+) 2024
The Mindful and Self-Compassionate Care Program (MASC): Reducing Stress for Caregivers of Persons with Dementia (Pilot Trial) TBD Christine Ritchie, Massachusetts General Hospital

MASC combines evidence-based skills from mindfulness programs, self-compassion programs, and behavioral management programs.

An open pilot trial was delivered to 10 informal caregivers of ADRD individuals

Caregivers of persons living with dementia 2025
Reducing Suicide Risk Among Aging Caregivers of Persons with AD/ADRD: Adapting, Implementing, and Evaluating Dialectical Behavior Therapy Skills Training Interventions Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD Jonathan Singer, Texas Tech University Dialectical behavior therapy skills training groups tailored to the unique experiences and needs of informal caregivers of persons with Alzheimer's Disease and related dementias to reduce suicide-related outcomes Informal caregivers (Ages 50+) of persons with Alzheimer's disease and related dementias 2026
Supporting Dementia Caregivers During Medicare Home Health: Developing the DECLARE Needs Assessment Intervention TBD Julia Burgdorf, Visiting Nurse Service of New York DECLARE, a self-assessment/web-based survey platform that asks caregivers about their needs and concerns, to improve home health care team communication with and in support of caregivers Home health staff and Alzheimer’s disease and related dementias (AD/ADRD) caregivers 2028
The Living Memory Home: Reducing Grief and Improving Relationships Between Home-based Patients with ADRD and Their Family Caregivers TBD Holly Prigerson, Joan and Sanford I Weill Medical College of Cornell University LMH-4-Dementia Care Pairs (LMH-4-DCP), a reminiscence-based intervention for family caregiver and person with dementia to address family caregivers' pre-loss grief and enhance relationship quality Caregivers and persons with dementia 2025
Caregiving While Black-LIVE: Empowering Black Dementia Caregivers to Navigate Care TBD Fayron Epps, Emory University Asynchronous/synchronous psychoeducation intervention that promotes caregiving self-efficacy in Black caregivers Adult family caregivers (Ages 40-75) to persons with Alzheimer’s disease and related dementia 2025
Plans4Care: Personalized Dementia Care On-Demand TBD Sokha Koueth, Plans4care Inc. Software system that provides caregivers of persons with Alzheimer's disease or Alzheimer's disease related dementia with personalized, evidence-based strategies on-demand to address self-identified care challenges Caregivers of persons living with Alzheimer's disease or Alzheimer's disease related dementia from a care setting 2024
Recharge Behavioral Therapy for Caregivers of Individuals with Alzheimer's Disease TBD Bruno Kajiyama, Photozig, Inc. Recharge behavioral therapy delivered through the recharge mobile app to help reduce depressive symptoms and alleviate stress of caregivers of individuals with Alzheimer’s disease Adult family caregivers (Ages 18+) to individuals with Alzheimer’s disease 2024
Improving Surrogate Communication and Decision Making
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Decisions About Cancer Screening in Alzheimer's Disease Decisions About Cancer Screening in Alzheimer's Disease (DECAD) Nicole Fowler, Indiana University-Purdue University Indianapolis A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening Dyads consisting of an older woman with Alzheimer's disease (Ages 75+) and a family caregiver (Ages undefined) 2024
A Video Intervention to Improve Decision Making in Early-Onset Dementia Caregivers Care Planning for a Loved One With Dementia: Knowledge, Preparing for Decisions, and Emotions Bradford Dickerson, Massachusetts General Hospital Video-based decision aids (user manuals) to improve decision making skills for caregivers of persons with early-onset dementia Caregivers (Ages 18+) of those with young-onset Alzheimer's disease and related dementias (onset age <65 years old) 2024
A Communication-based Intervention for Early Stage Dementia Patient-Caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden Developing a Communication Intervention for People with Memory Changes and Their Caregivers Sara Czaja, Joan and Sanford I Weill Medical College of Cornell University Communication-based intervention to improve preparedness for advance care planning (ACP) Adults with Alzheimer's disease and related dementias and their caregivers 2024
Safety in Dementia: An Online Caregiver Intervention "Safety in Dementia": An Online Caregiver Intervention Marian Betz, University of Colorado Anschutz Medical Campus RCT of the “Safety in Dementia” (SiD) online tool to address firearm access, thereby reducing injury risk, among informal caregivers of community-dwelling adults with dementia Informal caregivers of community-dwelling adults with dementia 2024
Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care Ellen Brown, Florida International University Assistive alternative communication device for persons living with dementia to communicate care preferences to caregiver and provider Dyads of caregivers and persons living with dementia 2025
Designing a Culturally Tailored Formal Care Decision-Making Intervention for African American Dementia Dyads and Families DECIDE: Dyads and Families Kalisha Johnson, Emory University Tailored strategies to support formal care decision-making processes African-American parent-adult daughter dyad 2026
Adapting Supported Decision Making to Promote Well-being and Improve Health Outcomes for Persons Living with Alzheimer's Disease and Alzheimer's Disease Related Dementias TBD Emily Largent, University of Pennsylvania A toolkit to improve decision-making Individuals living with Alzheimer's disease and related dementia (AD/ADRD), their care partners, and providers 2027
Enhancing Triadic Communication About Cognition for Older Adults with Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision TBD Allison Magnuson, University of Rochester COACH-Cog, an adapted tool to facilitate conversations about aging-related conditions, such as cognition, with older patients and their care partners Dyads of people living with dementia and their care partners 2027
The Role of Visit Audio Recordings in Triadic Dementia Care TBD Paul Barr, Dartmouth College HealthPAL, a visiting recording platform to improve tridiatic interpersonal communications IIndividuals with Alzheimer's disease and related dementia (AD/ADRD), care partners, and providers 2027
Adapting and Testing the Care Partner Hospital Assessment Tool (CHAT) for Use in Dementia Care Dementia Care Partner Hospital Assessment Tool Beth Fields, University of Wisconsin - Madison Care Partner Hospital Assessment Tool (CHAT): a novel approach designed to increase care partner preparedness for caregiving tasks during their family member or friends’ hospitalization Patients living with Alzheimer's disease and related dementia (AD/ADRD) and their care partners, healthcare system administrators, and clinicians 2027
Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease Negotiation Training for Caregiver Communication in AD Lee Lindquist, Northwestern University Negotiation and dispute resolution training program for caregivers of persons living with dementia Adult family caregivers of persons living with dementia that provide at least 10 hours weekly support 2025
Interventions in Formal Care Settings
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Nursing Home Pragmatic Clinical Trial of APPROACHES (Aligning Patient Preferences: A Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support) Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES Susan Hickman, Indiana University-Purdue University Indianapolis APPROACHES, an Advance Care Planning (ACP) Specialist Program to improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by nursing home staff Adults with Alzheimer's disease and related dementias, their family caregivers, and nursing home providers 2024
Optimal Medication Management in Alzheimer's Disease and Dementia Optimal Medication Management in Alzheimer's Disease and Dementia (Optimize) Elizabeth Bayliss, Kaiser Foundation Hospitals - Washington Pragmatic deprescribing intervention to improve medication management and improve overall health Older adults with Alzheimer's disease and related dementias or mild cognitive impairment 2024
METRIcAL - Music & MEmory: A Pragmatic TRIal for Nursing Home Residents with Alzheimer's Disease Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL) - Part 1 Vincent Mor, Brown University MUSIC & MEMORY (M&M) Music Program, a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences Nursing home residents with moderate to severe dementia 2024
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL) The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL) Abraham Brody, New York University Dementia Symptom Management at Home Program Hospice Edition (Aliviado Dementia Care-Hospice Edition), a multi-modal quality assurance performance improvement (QAPI) program for improving the quality of care provided to persons with dementia and support to their informal caregivers through hospice Hospice agencies 2024
Optimizing Mealtime (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents with Alzheimer's Disease and Related Dementias (ADRD) OPTIMAL in NH Residents With Dementia Wen Liu, University of Iowa Person-centered mealtime care intervention for nursing home residents with Alzheimer's disease and related dementias Interventionalists and nursing home residents living with Alzheimer's disease and related dementias (Ages 55+) 2024
Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients with Serious Illness Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2) (PICSI-H) Ruth Engelberg, University of Washington Electronic health record (EHR)-based Clinician Jumpstart intervention to promote goals-of-care communication for older patients with serious illness Older adults (Ages 65+; adults ages 65 - 79 must have 1+ chronic condition) 2024
Testing the Efficacy of FFC-AC-EIT in Patients with Alzheimer's Disease and Related Dementias Implementation of Function Focused Care in Acute Care Barbara Resnick, University of Maryland, Baltimore Function Focused Care for Acute Care (FFC-AC-EIT), a care interaction intervention to increase physical activity and prevent functional decline during hospitalization Older adults with Alzheimer's disease and related dementias (AD/ADRD) admitted to the hospital (Ages 55+) 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Can Value Champions Reduce Inappropriate Prescribing for People with Dementia? (Demo) Can Value Champions Reduce Inappropriate Prescribing for People With Dementia? Michael Parchman, Kaiser Permanente of Washington Health Research Institute Intervention led by clinical value champions embedded within primary care settings to decrease the use of potentially inappropriate medications in patients living with dementia Persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Cognitive Stimulation Therapy for Mild to Moderate Dementia (Pilot) Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial Michael Lepore, University of Maryland School of Nursing Cognitive Stimulation Therapy (CST), an online group intervention to actively engage and stimulate cognitive processes of persons living with dementia to reduce depressive symptoms Persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Collaborative Care Coordination Program for Alzheimer’s Disease and Related Dementias (Co-CARE-AD) (Demo) Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD) Xiaojuan Li, Harvard Pilgrim Health Care, Inc. Dementia Care Consultation (DCC) program, a collaborative care coordination program delivered by a care consultant to reduce patient healthcare utilization and improve caregiver knowledge and well-being Dyads of persons living with dementia and their caregiver 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Deprescribing of Diabetes Treatment Regimens in Long Term Care Residents with ADRD (Pilot) Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's Medha Munshi, Harvard Medical School An educational intervention directed at Long Term Care Facility (LTCF) staff to deprescribe and reduce the number of high risk medications (HRMs) in long term care facility (LTCF) residents with diabetes and ADRD Long-term care facility (LTCF) providers and LTCF residents with diabetes and Alzheimer's disease and related dementias (AD/ADRD) 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Implementation of a Telehealth Palliative Care Model for Persons with Dementia (Pilot) Implementation of a Telehealth Palliative Care Model for Persons With Dementia (IMPACT) Joan Carpenter, University of Maryland School of Nursing Telehealth intervention called Palliative Care Consultation in Post-Acute Care (PCC-PAC) to meet the needs of persons living with dementia newly admitted to nursing homes Persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Patient Priorities Care for Hispanics with Dementia (Pilot) Patient Priorities Care for Hispanics With Dementia (PPC-HD) Aanand Naik, University of Texas Health Science Center at Houston Patient Priorities Care (PCC), an EHR-based intervention to improve care decision strategies and align with patient priorities, for older adults with multiple chronic conditions Hispanic people living with dementia and chronic conditions 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Pilot Pragmatic Clinical Trial to Embed Tele-Savvy into Health Care Systems (Pilot) Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems Richard Fortinsky, University of Connecticut Health Center Tele-Savvy, an online program to improve caregiver mastery Family members/informal caregivers of people living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia (Pilot) Advance Care Planning (ACP) in Primary Care for Dementia (ADVANCE-PC) Annette Totten, Oregon Health and Science University ADVANCE-PC delivered using remote technology (ECHO), a communications and implementation support intervention to provide training and technical assistance tailored to the needs of primary care clinicians and clinics Persons living with dementia, clinicians, and staff 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Virtual Training for Latino Caregivers to Manage Symptoms of Dementia (Pilot) Virtual Training for Latino Caregivers to Manage Symptoms of Dementia Magaly Ramirez, University of Washington STAR-VTF is a program that teaches caregivers skills to reduce behavioral and psychological symptoms of dementia Caregivers of persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Implementation of MIND at Home Program in Primary Care for Patients Living with Dementia (Pilot) Implementation of MIND at Home Into Primary Care for People Living With Dementia Elizabeth Ciemins, American Medical Group Association MIND at Home is a dementia care coordination model that includes coordination between persons living with dementia, their care partner, a memory care coordinator and their provider Dyads of caregivers and individuals with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Mindfulness-Based Dementia Care Partner Program to Reduce Depressive Symptoms (Pilot) Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms Leah Hanson, HealthPartners Institute The Mindfulness-Based Dementia Care (MBDC) is a program for care partners of persons living with dementia to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care Care partners of persons living with dementia 2024
Improving Post-Diagnosis Dementia Care in Primary Care TBD Halima Amjad, Johns Hopkins Bayview Medical Center Pragmatic intervention to facilitate high quality, comprehensive post-diagnosis care and improve quality of care and patient outcomes Persons living with dementia, in traditional primary care settings 2025
Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults with Mild Cognitive Impairment, Alzheimer's Disease, and Related Dementia in Long Term Care Settings Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy Nilanjan Sarkar, Vanderbilt University Socially assistive robot to interact with long-term care setting residents with either dementia or mild cognitive impairment Person living with dementia or mild cognitive impairment in assisted living or nursing home facilities (Ages 70+) 2025
Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) Miguel Vazquez, University of Texas, Southwestern Medical Center Pragmatic trial of intensive blood pressure management Older adults (Ages 70+) 2025
Screening for Cognitive Impairment Following Critical Illness: Designing and Testing an Implementation Program to Support High Risk Older Adults TBD Jessica Palakshappa, Wake Forest University Cognitive screening program for incident mild cognitive impairment or Alzheimer's disease and related dementias Older adults with critical illness 2026
Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People with Alzheimer's Disease and Diabetes Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes April Savoy, Indiana University-Purdue University Indianapolis Shared Decision-Making Tool: new internet based interactive information visualizations designed to facilitate shared decision-making and recognize certain needs; Continuous Glucose Monitoring: a wearable device that continuously monitors glucose levels in near real-time Individuals with Dementia and Diabetes and their caregivers 2027
NIA AD/ADRD Health Care Systems Research Collaboratory: A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in PLWD from investigator (Pilot) A Patient-facing Tool To Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD) Donovan Maust, University of Michigan The intervention, EMPOWER, is an educational brochure focused on the risks associated with psychotropic and opioid polypharmacy that will be sent to participant via mail to "nudge”/encourage them to have discussions with the prescribing clinicians about the inappropriateness of the regimen to lower polypharmacy exposure for persons living with dementia Persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia (STOP-FALLS-D) (Pilot) Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia (STOP-FALLS-D) Elizabeth Phelan, University of Washington STOP-FALLS-D is an educational intervention to inform and nudge patients, their care partner(s), and their PCPs to work together to reduce use of CNS-active medications and prevent adverse outcomes (falls and injuries) associated with their use Persons living with dementia, their care partners, and their primary care providers (PCPs) 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Embedded Clinical Trial of Patient Priorities Care Among Persons Living with MCI and Dementia (Pilot) Perspectives on Embedded Patient Priorities Care (PEP Talks) Jennifer Carnahan, Indiana University Health Patient Priorities Care (PPC), is an evidence-based program to identify the goals and values of patients and care partners by 1) the clinician contacting the patient and care partner for a discussion of their priorities and 2) integration of priorities into the patient’s care plan Patients with mild cognitive impairment or dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Improving How People Living with Dementia Are Selected for Care Coordination (Demo) Improving How People Living with Dementia Are Selected for Care Coordination Lisa Kern, Joan and Sanford I Weill Medical College of Cornell University Intervention to identify and assign care coordinators to persons living with dementia based on their care partners’ self-reported difficulty with care coordination as compared to the usual approach of assigning care coordinators after hospital discharge Persons living with dementia 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients with Cognitive Impairment (Demo) Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients with Cognitive Impairment (Demo) Ira Hofer, Icahn School of Medicine at Mount Sinai CDS prompts, a series of prompts following the notification that a patient is at increased risk of postoperative delirium (POD) to promote best clinical practices for the prevention of POD Attending physicians and their adult patients with a history of cognitive impairment who will be undergoing surgery 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Reducing Inappropriate Medication Use for BPSD and Improving Health Outcomes in PLWD from investigator (Pilot) Reducing Inappropriate Medication Use for BPSD and Improving Health Outcomes in PLWD from investigator Helen Kales, University of California Davis Describe, Investigate, Create, Evaluate (DICE) is an intervention to manage behavioral and psychological symptoms of dementia (BPSD). DICE includes a 6-hour online modular training, manual, and additional training as needed coaching from a DICE trainer that will be completed by clinic social workers (called Onsite DICE Coordinators or ODCs). Persons living with dementia and their care partner dyads 2024
The Care Ecosystem Response to COVID-19: Accelerating Research on Dementia Care that Meets the Needs of Caregivers and Persons with Dementia during COVID-19 TBD Katherine Possin, University of California San Francisco The Care Ecosystem, a team-based care model that can lead to quality improvements for family caregivers and formal care providers Family caregivers and formal care providers 2025
Developing and Testing a Population Health Approach to Deprescribing and Optimizing Medications in Older Adults TBD Michelle Keller, Cedars-Sinai Medical Center Pharmacist-led deprescribing intervention aimed at reducing inappropriate medications Patients with with 5 medications prescribed and a face-to-face primary care encounter in the last year (Ages 65+) 2027
Developing, Implementing, and Evaluating a Caregiver and Elder Abuse Screening, Risk Assessment and Treatment to Improve Outcomes for Older and Vulnerable Adults with MCI/ADRD TBD Monique Pappadis, University of Texas Medical Branch Caregiver and Patient Abuse assessment For Older and Vulnerable populations (CAPA-OV), a screening and intervention tool for use in primary care settings to screen for elder abuse among older and vulnerable adults with mild cognitive impairment or Alzheimer's disease and related dementias (AD/ADRD), as well as the inclusion of a risk assessment for accompanying caregivers Persons living with dementia (Ages 65+), their caregivers, and healthcare providers 2024
The Effect of Smart Ambient Bright Light for Nursing Home Residents with Alzheimer's Disease and Related Dementias Smart Lighting for Nursing Home Residents With Dementia Ying-Ling Jao, Pennsylvania State University

The intervention is a smart ambient bright light (SABL) intervention which includes tunable LED lights, photosensors, and controllers

Nursing home residents with Alzheimer's disease and related dementia (AD/ADRD) (Ages 55+) 2024
Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons with Dementia TBD Gregg Gorzelle, Hopeful Aging LLC Making Connections Thru Music (MCTM) sessions, an evidence-based music and discussion intervention to improve engagement, enhance quality of life, and reduce behavioral expressions in persons with dementia Caregiving volunteers and resident living staff for persons living with dementia 2025
NIA AD/ADRD Health Care Systems Research Collaboratory: Partnering with Providers to Understand the Individualized Positive Psychosocial Intervention Outcomes of Interest for PLWD (Pilot) Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI) Katherine Abbott, Brown University A Individualized Positive Psychosocial Intervention (IPPI) program that tailors activities to resident preferences and provides people living with dementia with preference-based, person-centered care to improve their mood and reduce communication of distress. Persons Living With Dementia residing in nursing homes 2024
VoiceLove: An App-Based COMmunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE) TBD E. Wesley Ely, Voicelove LLC VoiceLove is a HIPAA-compliant mobile application that enables expanded family engagement for patients in the Intensive Care Unit (ICU) Clinicians, patients, and family members within medical, surgical, and coronary Intensive Care Units (ICU) 2024
Natives Engaged in Alzheimer's Research: Cognition After OSA Treatment Among Native American People TBD Denise Dillard, Washington State University Positive airway pressure therapy, a behavioral intervention for obstructive sleep apnea, to improve sleep quality, cognitive function, and vascular risk factors for Alzheimer's disease and related dementias American Indians from Strong Heart Study communities (Ages 55+) 2026
A Pragmatic Crossover Trial to Test the Effectiveness of a Novel Lighting System to Reduce Nighttime Falls in Persons with Alzheimer’s Disease and Related Dementias The Nightlight Falls Prevention Study Sheryl Zimmerman, University of North Carolina at Chapel Hill A lighting intervention to reduce nighttime falls Individuals with Alzheimer's disease and related dementia 2027
Enhancing Sleep Quality for Nursing Home Residents with Dementia: Pragmatic Trial Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase ( 40Winks ) A. Lynn Snow, University of Alabama Improve clinical outcomes for nursing home residents with Alzheimer's disease or related dementias by testing an evidence-based intervention to improve these residents' sleep Individuals with Alzheimer's disease or related dementia (Ages 50+) 2027
mGlide-Care: A mHealth Partnership with Care Givers to Improve HTN Management in Patients with Cognitive Impairment mGlide-Care: A mHealth Partnership with Care Givers to Improve HTN Management in Patients with Cognitive Impairment Kamakshi Lakshminarayan, University of Minnesota Twin Cities An intervention (mGlide-Care) to address uncontrolled hypertension in people with mild cognitive impairment and early stage Alzheimer's disease and related dementia (AD/ADRD) Participants with uncontrolled hypertension and early stage Alzheimer's disease and related dementia (AD/ADRD) or mild cognitive impairment (Ages 60 - 85) 2028
METRIcAL - Music & MEmory: A Pragmatic TRIal for Nursing Home Residents with ALzheimers Disease Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL) - Part 2 Vincent Mor, Brown University MUSIC & MEMORY (M&M) Music Program, music is preloaded on personalized music devices to increase nursing use of the music with residents Nursing home residents with moderate to severe dementia 2024
U.S. Deprescribing Research Network: PPC Deprescribing PPC Deprescribing Holly Holmes and Aanand Naik, University of Texas Health Science Center at Houston Patient Priorities Care (PPC), a three-step care plan regarding the implementation of priorities identification and alignment of deprescribing practices as part of the routine care of adults living with dementia Adults with dementia (ages 65+) and their caregivers 2024
ED-LEAD: Emergency Departments LEading the transformation of Alzheimers and Dementia care ED-LEAD: Emergency Departments LEading the transformation of Alzheimers and Dementia care Joshua Chodosh, New York University School of Medicine Emergency and post-emergency care through patient-care partner focused interventions: 1) Emergency Care Redesign; 2) Nurse-led Telephonic Care; and 3) Community Paramedic-led Transitions Intervention Persons living with dementia who visit the emergency department (Ages 66+) 2028
Testing the Pain-CPG-EIT Testing the Pain Clinical Practice Guideline Barbara Resnick, University of Maryland, Baltimore The study will evaluate the efficacy and treatment fidelity of an intervention to improve assessment, diagnosis and management of pain (Pain Management Clinical Practice Guideline, PAIN-CPG-EIT) among nursing home residents living with dementia Nursing home residents living with dementia (Ages 65+) 2028
Interventions in Home or Informal Care Settings
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Meaningful Activity Intervention for Individuals with Early-Stage Dementia: Involving the End User in Intervention Design User-Led Meaningful Activity and Early-Stage Dementia Natalie Regier, Johns Hopkins Bayview Medical Center Service user-led meaningful activity intervention to treat mild dementia People that are mild or early stages of dementia (Ages 60+) 2024
A Randomized Controlled Trial of Visual Cues, Signage, and Spaced-Retrieval Education within Long Term Care Communities to Assist with Wayfinding Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding Rebecca Davis, Grand Valley State University Assistive cues (salient cues) plus spaced retrieval education to help older adults who live in senior communities remember the presence and function of the environmental wayfinding cues Residents from 12 senior assisted-living facilities (Ages 62+) 2024
MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-Living Persons with Dementia, their Families, and Senior Volunteers MEMORI Corps: Activity-based Companion Care for Dementia (MEMORI Corps) Quincy Samus, Johns Hopkins Bayview Medical Center Activity-based home healthcare to treat people with dementia People with dementia (Ages 55+) and caregivers (Ages 18+) 2024
Improving Everyday Task Performance through Repeated Practice in Virtual Reality Improving Everyday Task Performance Through Repeated Practice in Virtual Reality. (VKI) Tania Giovannetti, Temple University Virtual reality training intervention for persons with Alzheimer's Disease to improve performance of everyday tasks Older adults with mild to moderate Alzheimer's disease (Ages 65+); Informants with knowledge of person with Alzheimer's disease's level of function 2024
Care4AD: A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementias Care Coordination System for People With Dementia Vaziri Ashkan, BioSensics Care4AD, a comprehensive care platform to improve care for people with Alzheimer's disease Adults with mild to moderate Alzheimer's disease (Ages 56+) 2024
Impact of Novel Rehabilitative Approaches for Dysphagia in Patients with Alzheimer's Disease and Related Dementias Interventions for Patients With Alzheimer's Disease and Dysphagia Nicole Rogus-Pulia, University of Wisconsin - Madison Dysphagia rehabilitative interventions (lingual strengthening and saliva substitute use) to improve swallowing-related outcomes Older adults with diagnosis of dementia, cognitive impairment, or memory loss (Ages 55 - 90) 2024
Decision Making Among Older Adults: the AUTO study Advancing Understanding of Transportation Options (AUTO) Marian Betz, University of Colorado Anschutz Medical Campus Web-based driving decision aid (DDA), an online tool that guides an individual to optimize decision-making Older drivers without severe cognitive impairment (Ages 70+) and family members 2024
A Dyadic Approach for a Remote Physical Activity Intervention in Adults with Alzheimer’s Disease and their Caregivers A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers Lauren Ptomey, University of Kansas Medical Center Moderate physical activity intervention for adults with Alzheimer’s Disease and their Caregivers to improve mobility Adults with mild moderate Alzheimer's disease and their caregivers (Ages 55+) 2024
Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease Study (D-PRESCRIBE-AD) A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease (D-PRESCRIBE-AD) Jerry Gurwitz, University of Massachusetts Medical School Patient/caregiver-centered, multifaceted educational intervention on inappropriate prescribing Older adults with Alzheimer's disease and related dementias (AD/ADRD) 2025
Using Design Thinking Approaches to Tailor a Dyadic Behavioral Sleep Intervention for Persons Living with Dementia and Their Caregivers TBD Glenna Brewster Glasglow, Emory University T-Dyadic Sleep, a cognitive behavioral therapy for insomnia (CBTI) intervention to examine acceptability and feasibility as well as preliminary efficacy on objective and subjective sleep outcomes Persons living with mild cognitive impairment or early-stage dementia and their caregivers 2026
Music-based Intervention for Insomnia in Persons Living with Dementia and their Caregivers TBD Darina V. Petrovsky, Rutgers Biomedical And Health Sciences Tailored music-based mobile application aimed at improving insomnia symptoms in persons living with dementia Underrepresented community-dwelling persons living with dementia and their caregivers 2026
A Dyadic Approach to Improve Sleep and Well-being Among Persons with Alzheimer's Disease and Their Caregivers A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers Yeonsu Song, University of California Los Angeles Dyadic sleep intervention to improve subjective and objective sleep quality Dyads of people living with dementia and their care partners 2027
Addressing Hearing Loss as a Common Unmet Contributor to Neuropsychiatric Symptoms TBD Esther Oh, Johns Hopkins Bayview Medical Center A hearing care intervention to treating neuropsychiatric symptoms Individuals living with Alzheimer's disease and related dementia (AD/ADRD) 2027
Improving Person-Environment Fit of Community-Residing Older Adults with Dementia Through Assessment and Individualized Intervention TBD Elizabeth Rhodus, University of Kentucky Harmony at HOME will provide caregiver training for assessment of the environment as an antecedent to behaviors of the person with Alzheimer's disease and related dementias & implementation of environmental cueing as a tool to create a supportive environment for functional behaviors and activity participation Persons living with dementia and their care partners 2027
Randomized Clinical Trial of a Brief, Anxiety Intervention for Mild Cognitive Impairment/mild Alzheimer’s Disease and their Care Providers Treatment of Stress and Anxiety in MCI/Mild ADRD Norman Schmidt, Florida State University Cognitive anxiety sensitivity treatment (CAST): a brief, fully computerized CBT-based intervention in people living with mild cognitive impairment Dyads consisting of persons with mild cognitive impairment or mild Alzheimer's disease and related dementias (AD/ADRD) and their care partners 2027
Home Alone: Developing a Home-Based Intervention for People with Cognitive Impairment Who Live Alone Home Alone Joseph Gaugler, University of Minnesota Twin Cities Home Alone combines behavioral activation (BA) with other evidence-based intervention approaches (i.e., Tailored Activity Program/TAP; Skills2Care®) that target the environment in order to tailor activity that is fulfilling and meaningful to persons with cognitive impairment Persons with cognitive impairment who live alone 2024
Development of a Reminiscence Therapy Online Platform with Machine Learning to Increase Engagement with People Living with Dementia and Their Care Partners LifeBio Memory Digital Reminiscence Platform Lisbeth Sanders, LifeBio Inc LifeBio Memory, an online platform that stores stories, videos, and photos and uses information to make personalized reminiscence therapy exercises Adult staff (Ages 18+) in assisted living facility with dementia care residents in assisted living care setting (Ages 55+) 2024
eAlign: A Patient Portal-based Intervention to Align Medications with What Matters Most TBD Ariel Green, Johns Hopkins Bayview Medical Center eALIGN, a patient portal intervention to align medication decisions with persons living with Alzheimer's disease and related dementias (AD/ADRD) and care partners' goals, provide care partner training in the use of nonpharmacologic methods to address behavioral and psychological symptoms of dementia, and reduce polypharmacy and potentially inappropriate medication use Older adults with diagnosis of Alzheimer's disease and related dementia who receive 5 or more chronic daily medications (Ages 65+) 2027
Promoting Independence with Compensatory Cognitive Rehabilitation: A Pilot Clinical Trial for Early-Stage Alzheimer's Disease Promoting Independence With Compensatory Cognitive Rehabilitation Alyssa Lanzi, University of Delaware A behavioral treatment, Structured External Memory Aid Treatment (SEMAT), to promote independent living skills Adults with mild cognitive impairment (Ages 65 - 85) 2026
U.S. Deprescribing Research Network: Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living Jennifer Kim, Vanderbilt University A patient/ surrogate-centered deprescribing intervention adapted for dementia (Shed-MEDS) to reduce exposure to unnecessary or potentially harmful medications among residents with dementia living in an assisted living facility Residents of an assisted living facility with dementia who are taking 5+ medications or 1 potentially inappropriate medication 2024
A Stakeholder Derived Intervention to Enhance Technology Engagement and Reduce the Emotional Divide in Distance Caregiving of Older Adults with Cognitive Impairment TBD Alyssa Weakley, University of California Davis Interactive-Care (I-Care), remote caregiver platform to improve everyday functioning and independence of care receivers, remote caregiver involvement, and the emotional bond between the dyad Mild Alzheimer's disease and related dementia / cognitively impaired care receiver and remote caregivers 2028
Developing a Nonpharmacological Pain Intervention for Community Dwelling Older Adults with Dementia TBD Annalisa Na, Drexel University A program where participants will start each session with pain, vital signs, and environmental assessments; then receive an individualized home-based exercise program People living with mild to very mild dementia with osteoarthritis (Ages 65+) and their caregiver 2027
A Social Engaging Restorative Virtual Environment (SERVE) Volunteer Intervention to Support Social Engagement and Well-being in Older Adults with Cognitive Impairment TBD Saleh Kalantari, Cornell University A VR-based intervention to improve the wellbeing and quality of life of older adults with mild cognitive impairment Older adults with mild cognitive impairment and non-impaired older adult volunteers 2028
Long-Term Care Services and Supports and Care Coordination
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Improving Outcomes for Family Caregivers and Older Adults with Complex Conditions: The Adult Day Service Plus Program Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program (ADS Plus) Laura Gitlin, Johns Hopkins Bayview Medical Center Adult day service (ADS) Plus, including care management, referral/linkage, education about dementia, situational counseling, emotional support, stress reduction techniques, and skills to manage behavioral symptoms Caregivers initially enrolling their relative in one of the Adult Day Service sites (Ages 21+) 2024
The Care Ecosystem: Navigating Patients and Caregivers Through Stages of Dementia Care Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial Katherine Possin, University of California San Francisco Navigated Care, a comprehensive longitudinal continuing care program that supports model care for persons with dementia and their family caregivers Persons with dementia (Ages 45+) and caregiver dyads 2023
Training the Long-Term Services and Supports Dementia Care Workforce in Provision of Care to Sexual and Gender Minority Residents MN Inclusive LTSS for LGBTQ Seniors (MILLS) B.R. Simon Rosser, University of Minnesota Twin Cities
  1. Training To Serve (TSS) Curriculum: provides resources and training for long-term services and supports (LTSS) providers;
  2. Online Equivalent Intervention (eTTS): TTS will be translated using e-learning best practices. Additions will include new optional modules.
  3. Waitlist Control: Those assigned to the waitlist control complete baseline surveys and then, following randomization, wait for 6 months before training.
Long-term services and support staff (Ages 18+), Sexual and Gender Minority (SGM) residents, and SGM resident caregivers 2026
Improving Information Sharing Between Family Caregivers and Home Care Aides Caring for Persons Living with ADRD TBD Chanee Fabius, Johns Hopkins Bayview Medical Center A feasibility test of a home care role and preference guide designed to improve information sharing between family caregivers and home care aides of persons living with Alzheimer's disease and related dementias (AD/ADRD) receiving Medicaid Home and Community-Based Services in Maryland Family caregivers and home care aides of older adults living with Alzheimer's disease and related dementia (AD/ADRD) 2027
Improving Alzheimer's Disease and Related Dementias Care in Rural Areas TBD Patricia Prusaczyk, Washington University in St. Louis A communication and care coordination tool for providers of patients with Alzheimer's disease and related dementias Providers of care for individuals living with Alzheimer's disease and related dementias 2026
Palliative and End-of-Life Care
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Indiana Palliative Excellence in Alzheimer Care Efforts-RCT Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) Greg Sachs, Indiana University-Purdue University Indianapolis Palliative care to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention People with moderate to severe stage dementia (Ages 65+) 2024
Transforming Residential Palliative Care for Persons with Dementia Through Behavioral Economics and Data Science: Promoting Advance Care Planning Using a Prognosis and Outcome Information Sheet Among Persons with Advanced Dementia in Long-term Services and Support Facilities (Pilot) Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia Donald Sullivan, Oregon Health and Science University Education information sheet for the promotion of advanced care planning (ACP) among family members of persons with advanced dementia in long-term services and support facilities Clinicians and family members of persons with advanced dementia in long-term services and support facilities 2024
Transforming Residential Palliative Care for Persons with Dementia Through Behavioral Economics and Data Science: Systematic Identification of NH Residents with 6-month Mortality Risk for Hospice Informational Referral (Pilot) TBD Laura Hanson, University of North Carolina at Chapel Hill A machine-learning mortality prediction model to identify nursing residents with late-stage Alzheimer's disease and related dementias appropriate for hospice informational referrals to reduce goal-discordant hospital transfers Nursing home residents with late-stage Alzheimer's disease and related dementia 2024
Enhanced Dementia Instruction and Tool in Home Hospice Care (EDITH-HC) Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians (EDITH-HC) Elizabeth Luth, Rutgers Biomedical And Health Sciences Training program and tool to improve clinicians' knowledge of dementia-related challenges in home hospice care, reduce family caregiver burden, and reduce hospice disenrollment Nurses or social workers who provides home hospice to persons living with dementia and family caregivers 2024
PCplanner: Operationalizing Needs-focused Palliative Care for Older Adults in Intensive A Needs-focused Palliative Care Intervention for Older Adults in ICUs (PCplanner) Christopher Cox, Duke University PCplanner-augmented care and PCplanner mobile, augmented collaborative palliative care that will allow patients and their family members to report their needs in a platform viewable by ICU physicians to 1) reduce family caregivers' unmet needs and psychological distress, 2) increase the frequency of goal concordant treatment among older adult patients, and 3) reduce hospital length of stay Older adults (Ages 65+) managed in an ICU and their family members (Ages 18+), and physicians and nurses (Ages 18+) from academic and community settings 2024
Palliative Care Needs and Outcomes for Dementia Patients Supportive Care for Cognitively Impaired Patients and Families Vyjeyanthi S. Periyakoil, Stanford University Nurse-led early palliative care intervention (EPC) involving conducting systematic assessment and providing coaching to patients to improve care and well-being Community-dwelling Stanford ADRC participants (Ages 60 - 100) 2024
Palliative Care for Persons with Late-stage Alzheimer's and Related Dementias and their Caregivers: A Randomized Clinical Trial Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers (ADRD-PC) Laura Hanson, University of North Carolina at Chapel Hill Dementia-specific palliative care intervention involving caregiver education and transitional care Dyads of hospitalized patients with late stage Alzheimer's disease and related dementias (AD/ADRD) and their family caregivers 2025
UPLIFT-AD (Utilizing Palliative Leaders in Facilities to Transform Care for Alzheimer's Disease) Intervention Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease (UPLIFT-AD) Kathleen Unroe, Indiana University-Purdue University Indianapolis Palliative care intervention utilizing palliative care champions to consult and help surrogate decision makers Surrogate decision makers for persons living with dementia in nursing homes 2025
LEADing End-of-Life Dementia Care Conversations LEADing Dementia End-of-Life Planning Conversations (LEAD) Kara Dassel, University of Utah Tool to help persons with preclinical awareness of Alzheimer's disease and related dementia risk and those with early-stage cognitive impairment to begin advance care planning conversations with a care partner Community-dwelling pairs consisting of persons in the preclinical or early stage of Alzheimer's disease and related dementia (AD/ADRD) and their care partner 2027
Palliative Care at Home for Patients With Dementia Palliative Care at Home for Patients with Dementia Nathan Goldstein, Icahn School of Medicine at Mount Sinai A new novel home-based palliative care intervention for patients with advanced AD/ADRD and their caregivers. Dyads will be cared for by a pyramid of palliative care and dementia care trained providers who will continue to work with the patient / caregiver through face-to-face visits, video visits, and (at least) weekly phone calls for 12 months Older adults (ages 65+) with advanced dementia, based on Global Deterioration Score (GDS) >6 who are impairment in at least one activity of daily living (ADL) and their family caregiver 2027
A Novel Intervention to Improve Care for Older Sexual and Gender Minority (SGM) Adults with Serious Illness and Especially Those with Alzheimer's and Related Dementias (ADRD) TBD Carey Candrian, University of Colorado Anschutz Medical Campus 1) Stakeholder-based behavioral intervention: trains hospice interdisciplinary staff in person-centered communication to promote authentic end-of-life care for sexual and gender minority patients (SGM) patients; and 2) Communication training intervention: teaching hospice interdisciplinary staff to sensitively collect and incorporate sexual orientation and gender identity (SOGI) data to more effectively communicate to accomplish assessment and person-centered care when providing end of life Hospice interdisciplinary team (IDT) staff, sexual and gender minority (SGM) former/current patients, and SGM older adults current/former caregivers for people living with Alzheimer's disease and related dementia (AD/ADRD) 2027
Staff Training and Professional Development
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Adapting an Evidence-Based Program that Improves Oral Hygiene and Health for Assisted Living Residents with Dementia Oral Hygiene in Assisted Living Sheryl Zimmerman, University of North Carolina at Chapel Hill A program to provide daily mouth care to reduce bacteria in the mouth that can lead to aspiration pneumonia for assisted living residents Residents with dementia, care staff, and dental hygienists (Ages 18+) 2024
Nursing Home Prevention of Injury in Dementia (NH PRIDE) Nursing Home Prevention of Injury in Dementia (NH PRIDE) Sarah Berry, Hebrew SeniorLife / Hebrew Rehabilitation Center Centralized Injury Liaison Service (ISL) to decrease injurious falls in nursing home residents Nursing home residents at high risk for injurious falls, and nursing home staff at participating facilities 2024
Changing Talk Online Training (CHATO): A National Trial to Reduce Behavioral Symptoms in Long Term Care Residents with Alzheimer's Disease and Other Dementias Changing Talk Online Training (CHATO) National Trial Kristine N. Williams, University of Kansas Medical Center Elderspeak and communication training to reduce behavioral symptoms in long term care settings Nursing home staff 2026
Evaluating a National Person-Centered Training Program to Strengthen the Dementia Care Workforce TBD Sheryl Zimmerman, University of North Carolina at Chapel Hill Two training arms (essentiALZ alone and essentiALZ + ECHO) in terms of adoption, reach, and reaction. The trial will determine effectiveness of two training arms in relation to each other and to a control arm Staff at Assisted Living facilities 2027
Improving Health Equity in Long-term Care Residents with Dementia: The Role of Race and Ethnicity in Resident-to-Resident Aggression TBD E-Shien Chang, Joan and Sanford I Weill Medical College of Cornell University A new staff education module aimed to prevent and mitigate race/ethnicity-related resident-to-resident aggression in long-term care facilities Nursing home healthcare providers (Ages 18+) 2028
Technology Assisted Monitoring and Care
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Commercializing In-Home Supportive Technology for Dementia Caregivers In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Spanish Language Homes Gene Wang, People Power Company People Power Caregiver is a newly developed hardware and software system that is designed to create a safer and more supportive home environment for caregivers and persons with dementia and mild cognitive impairment; People Power Caregiver combines modern Internet-of-Things and artificial intelligence technologies Dyads of caregivers and individuals with dementia or mild cognitive impairment who live in a Spanish language home. Caregivers must have an iPhone or Android phone. 2024
Commercializing In-Home Supportive Technology for Dementia Caregivers In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Rural Homes Gene Wang, People Power Company People Power Caregiver is a newly developed hardware and software system that is designed to create a safer and more supportive home environment for caregivers and persons with dementia and mild cognitive impairment; People Power Caregiver combines modern Internet-of-Things and artificial intelligence technologies Dyads of caregivers and individuals with dementia or mild cognitive impairment who live in a rural home. Caregivers must have an iPhone or Android phone. 2024
Commercializing In-Home Supportive Technology for Dementia Caregivers In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Wearables Gene Wang, People Power Company People Power Caregiver is a newly developed hardware and software system that is designed to create a safer and more supportive home environment for caregivers and persons with dementia and mild cognitive impairment; People Power Caregiver combines modern Internet-of-Things and artificial intelligence technologies Dyads of caregivers and individuals with dementia or mild cognitive impairment in homes with Apple Watch. Caregivers must have an iPhone or Android phone. 2024
Robot-Assisted Cognitive Training for Socially Isolated Older Adults with Mild Cognitive Impairment Robot-Assisted Cognitive Training for Socially Isolated Older Adults with Mild Cognitive Impairment (MCI) Jenay Beer, Applied Universal Dynamics, Corp. Socially-assistive robot to deliver cognitive training in the form of a music (piano) learning intervention Older adults with mild cognitive impairment (Ages 65+) 2024
Social Assistive Robot Interface for People with Alzheimer's and Other Dementias to Aid in Care Management SimpleC Wellness Platform With Social Robot Interaction (Long-term) Daniel Hedin, Advanced Medical Electronics Corp. Socially-Assistive Robot (SAR) to engage persons living with dementia in a detailed natural language conversation as psychosocial support Persons living with dementia and their caregivers who live (or work) in an Assisted Living Facility. 2023
A Mobile Informatics Solution to Aid in Memory A Mobile Informatics Solution to Aid in Memory Gary Havey, Advanced Medical Electronics Corp. Smartwatch Reminder (SR) system, to automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the person with memory concerns when family or friends visit Dyads of persons with memory concerns (Ages 30 - 70) and their care partners (Ages 21+) 2024
Using Gamification, Predictive Analytics, Artificial Intelligence, and Alexa Voice to Optimize User Experience for Individuals Living with AD/ADRD and Their Caregivers Efficacy of Gamification in Enhancing User Engagement Matthew Golden, MapHabit, Inc. MapHabitTM system, an assistive technology app that helps accomplish activities of daily living, maintain independence, and improves overall quality of life for users Older adults with Alzheimer's disease and related dementias (AD/ADRD) 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: Optimizing Dementia Caregivers' Biological Clock through Lifestyle Change (Pilot) Self-Care for Dementia Caregivers: User-Centered Design Sarah Stahl, University of Pittsburgh iCARE is a multicomponent intervention that uses mobile technology and motivational health coaching to optimize behaviors that keep the body’s biological clock in sync: sleep, exercise, and social activities Caregivers of persons living with dementia 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: Protecting Alzheimer Caregivers using Technology through StayingSharp (PROACTS) (Pilot) Protecting Alzheimer's Caregivers Using Technology Through Staying Sharp (PROACTS) Chao-Yi Wu, Oregon Health and Science University Staying Sharp, an online multi-component health intervention to promote a healthier lifestyle and improved skills for coping with the stress involved in dementia caregiving Caregivers of persons with Alzheimer's disease and related dementias (AD/ADRD) 2024
Motor Learning of Fall Resistant Skills from Laboratory-Induced Falling Among People with Alzheimer's Disease Perturbation Training Reduces Falls in People With AD (STAD) Feng Yang, Georgia State University Perturbation training, a motor learning intervention to prevent falls Older adults with mild Alzheimer's disease 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia (SHARP-CG) (Pilot) Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia (SHARP-CG) Raina Croff, Oregon Health and Science University The SHARP Android application preloaded with 72 GPS-linked routes, each route with three “Memory Markers” (historical localized images with two associated questions) designed to prompt conversational reminiscence about local Black history, culture, and life experiences while walking Triads of 1) primary caregiver, 2) caregiver support person, and 3) African American person with early-stage dementia 2024
Reducing Loneliness of Older Adults in Long Term Care Facilities through Collaborative Augmented Reality TBD Nilanjan Sarkar, Vanderbilt University HMD-AR, a collaborative head mounted display augmented reality to maximize social connection and engagement Older adults residing in LTC facilities, family members of the older adults, and formal staff caregivers employed in the Department of Recreational Activities 2024
Effectiveness and Adoption of a Smart Home-based Social Assistive Robot for Care of Individuals with Alzheimer's Disease TBD Sajay Arthanat, University of New Hampshire Mobile Assistive Robot with Smart Sensing (MARSS) is a smart home-based social assistive robot with multi modal care protocols which combines best practices and existing research on home automation, human-robot interaction, and Alzheimer's disease care giving Individuals with Alzheimer’s diseases and caregiver dyads 2027
Using Rendever to Improve the Quality of Life of Older Adults with Cognitive Impairments in Senior Living Communities and Their Family Members Who Live at a Distance Technology and Family Thriving Study (Thrive) Kyle Rand, Rendever Rendever virtual reality (VR) platform designed to improve quality of life of residents with Alzheimer's disease and related dementias in senior living communities and their adult children who live at a distance Dyads of residents with Alzheimer's disease and related dementias in senior living communities and their adult children 2024
Telehealth-Enhanced Patient-oriented Recovery Trajectory After Intensive Care Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care (TelePORT) Leanne Boehm, Vanderbilt University Collaborative telemedicine-delivered ICU-Recovery Clinic intervention to identify and improve long-term cognitive impairment, physical and mental health dysfunction, social integration, and self-management behaviors for older critically ill adults Older adults treated in a medical or surgical ICU for acute respiratory failure and/or septic shock and at high risk for developing Post-Intensive Care Syndrome (Ages 45+) 2028
A Light Exposure Tracker Designed to Improve the Circadian Entrainment for Alzheimer Disease Patients - Aim 2 TBD Erik Page, Blue Iris Labs, Inc. Speck Sr., an active lighting intervention designed to add morning light and reduce evening light to optimize light exposure and support circadian entrainment Healthy adults and adults living at home with mild cognitive impairment or early stage Alzheimer's disease and related dementias 2024
A Light Exposure Tracker Designed to Improve the Circadian Entrainment for Alzheimer Disease Patients - Aim 1 TBD Erik Page, Blue Iris Labs, Inc. Speck Sr., an active lighting intervention designed to add morning light and reduce evening light to optimize light exposure and support circadian entrainment Healthy older adults 2024
Over-The-Counter Hearing Aid Treatment for Adults with Cognitive Decline Due to Alzheimer's Disease and Related Dementias TBD Pamela Souza, Northwestern University Hearing or communication intervention to improve cognition and overall communication ability Adults with mild hearing loss and early-stage Alzheimer's disease, related dementia, or mild cognitive impairment (Ages 60+) 2025
Smartphone-based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia TBD Michael Scullin, Baylor University Prospective memory training for persons with mild cognitive impairment or mild dementia using smart-phone based strategies People with mild cognitive impairment or mild dementia from underserved or digitally disadvantaged populations and their study partners 2028
Other
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Accessible Hearing Care for Reduction of Disruptive Behaviors and Caregiver Burden in Dementia HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment Carrie Nieman, Johns Hopkins Bayview Medical Center Communication intervention delivered at home (counseling program combined with a low-cost, over-the-counter amplification device) to optimize hearing and communication for older adults with Alzheimer's disease and related dementia Older adults with dementia and their caregivers (Ages 18+) 2024
Promoting Seniors Health with Home Care Aides: A Randomized Controlled Trial Promoting Seniors' Health With Home Care Aides Naoko Muramatsu, University of Illinois at Chicago Healthy Moves for Aging Well (Healthy Moves), a safe physical activity program delivered by home care aides, which consists of a brief motivational enhancement and three movements to be performed in a seated position Pairs of of eligible patients and their home care aides 2024
Pragmatic Trial of the Effectiveness and Cost-Effectiveness of Dementia Care D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care (D-CARE) David Reuben, University of California Los Angeles Pragmatic intervention to compare clinical effectiveness and cost-effectiveness of community-based dementia care and health system-based care Dyads of persons with dementia and their primary caregivers (Ages 18+) 2024
PLAN: Dementia Literacy Education and Navigation for Korean Elders with Probable Dementia and their Caregivers PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers (PLAN) Hae-Ra Han, Johns Hopkins Bayview Medical Center PLAN, a dementia literacy training used to train community health workers to improve caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life Community health workers and dyads of individuals with probable dementia (Ages 65+) and their caregiver (Ages 18+) 2024
Behavioral Change Following Culturally-Informed Biomarker Disclosure in Alzheimer’s Disease Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure (SHARED III) Annalise Rahman-Filipiak, University of Michigan Diagnostic Disclosure Protocol, where participants receive information about current cognitive performance to assess long-term behavior, safety, and efficacy in patients with amnestic Mild Cognitive Impairment (aMCI) following biomarker disclosure Adults diagnosed with amnestic mild cognitive impairment within the past 12 months (Ages 50+) 2026
Primary Care Based Collaborative Approach to Care Management for Older Adults with Dementia TBD Stephanie Nothelle, Johns Hopkins Bayview Medical Center Develop and implement a practical primary care based intervention to facilitate collaboration across care management programs Older adults with Alzheimer's disease and related dementia (AD/ADRD) 2026
Natives Engaged in Alzheimer's Research: Indians Transforming Alzheimer's Care Training (INTACT) TBD Patrik Johansson, Washington State University INTACT, a clinic-level intervention to improve Alzheimer's disease and related dementias diagnosis and quality of care for American Indian and Alaska Natives Rural clinics serving American Indian and Alaska Natives 2026
Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia Telehealth in Lewy Body Dementia Bhavana Patel, University of Florida Telemedicine model of Lewy Body Dementia interdisciplinary care Individuals living with Lewy Body Dementia and their caregivers 2026
A Novel Platform to Facilitate Provider Adoption of Cognitive Care Planning TBD Bin Huang, Braincheck, Inc. BC-Care (BrainCheck), a cognitive care planning tool that integrates patient, provider, and caregiver input to generate personalized Alzheimer's disease and related dementias (AD/ADRD) recommendations and follow-up care to be implemented during an AD/ADRD's patient's medical visit Adults with an existing diagnosis of mild to moderate dementia (Ages 65+), their caregiver, and their health care provider 2024
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults with Mild to Moderate Alzheimer's Disease Effect of Acetylcholinesterase Inhibitors on Bone Metabolism Richard Lee, Duke University Donepezil, an acetylcholinesterase inhibitor, compared to placebo to measure the effect on fracture risk factors including bone mineral density (BMD), bone turnover markers, and bone quality Older adults with biomarker-diagnosed Alzheimer’s disease and related dementias at the Duke Memory Disorders Clinic 2025
A Pilot of Memory Support System for Older Chinese Americans with Mild Cognitive Impairment TBD Clara Li, Icahn School of Medicine at Mount Sinai Chinese adapted memory support system that uses a day planner and note-taking system as a support tool to train individuals with mild cognitive impairment to perform their instrumental of activities of daily living independently Chinese American older adults (Ages 65+) and their care partners who are primarily Mandarin and Cantonese-speaking 2025

Section 5: Diagnostic Tools, Assessments, & Imaging Studies

Diagnostic Tools, Assessments, & Imaging Studies
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Digital Detection of Dementia Florida Replication Site Pragmatic Cluster-Randomized Controlled Comparative Effectiveness Trial (D3) Digital Detection of Dementia (D Cubed) Studies (Dcubed) Malaz Boustani, Indiana University-Purdue University Indianapolis The Passive Digital Marker (PDM), a Machine Learning (ML) algorithm, and the Quick Dementia Rating Scale (QDRS), a patient reported outcome (PRO) tool, to detect cognitive impairment and improve the annual rate of new documented Alzheimer's disease and related dementias (AD/ADRD) diagnosis in primary care practices Eligible primary care clinics within the UMiami Health system and adults with at least one visit to a primary care physician within the past year (Ages 65+) 2025
Digital Detection of Dementia Pragmatic Cluster-Randomized Controlled Comparative Effectiveness Trial (D2) Digital Detection of Dementia (D Cubed) Studies (Dcubed) Malaz Boustani, Indiana University-Purdue University Indianapolis The Passive Digital Marker (PDM), a Machine Learning (ML) algorithm, and the Quick Dementia Rating Scale (QDRS), a patient reported outcome (PRO) tool, to detect cognitive impairment and improve the annual rate of new documented Alzheimer's disease and related dementias (AD/ADRD) diagnosis in primary care practices Eligible primary care clinics within the Eskenazi Health system and adults with at least one visit to a primary care physician within the past year (Ages 65+) 2025
Biomarker Predictors of Memantine Sensitivity in patients with Alzheimer's Disease Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease Neal Swerdlow, University of California San Diego Identify sensitivity levels of memantine, an NMDA receptor antagonist approved for treatment of moderate-to-severe Alzheimer's disease Older adults with Alzheimer's disease 2024
Development of an Ophthalmic Diagnostic Probe for Cerebral Amyloid Angiopathy in Patients TBD Stella Sarraf, Amydis Diagnostics Inc. Ophthalmic diagnostic probe to detect cerebral amyloid angiopathy (vascular disease) Healthy adults and Cerebral Amyloid Angiopathy adult patients 2024
Emergency General Surgery Delirium Recovery Model: A Collaborative Care Intervention Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors Ben Zarzaur, University of Wisconsin - Madison Emergency General Surgery Delirium Recovery Program, a care collaborative program to cognitive, functional and psychological recovery after episode(s) of delirium Surgery patients who suffer at least one episode of delirium in the post-operative period (Ages 65+) 2027
Evaluating Cognitive Impairment as a Moderator of Locomotor Learning in Older Adults Post-stroke Cognition and Motor Learning Post-stroke Kristan Leech, University of Southern California Biomechanical analyses, neuropsychological assessments, and brain imaging techniques to examine the structural integrity of the dorsolateral prefrontal cortex in explicit locomotor learning and inform the development of a gait rehabilitation intervention for older adults post-stroke Older adults with post-stroke cognitive impairment 2026
Identifying and Supporting Patients with Undiagnosed Dementia Using the EHR Risk of Alzheimer's and Dementia Assessment Rule (eRADAR): A Pilot Clinical Trial The Brain Health Study: A Pragmatic, Patient-Centered Trial Sacha Dublin, Kaiser Foundation Hospitals - Washington EHR dementia screening tool to follow up with high risk patients with potential undiagnosed dementia Older adults enrolled in Kaiser Washington or UCSF care within the past 2 years with no prior diagnosis of dementia (Ages 65+) 2024
Integrating Home-based Video Teleneuropsychology into Clinical Practice: Typical Versus Atypical Alzheimer's Disease VIdeo Telehealth in Alzheimer's: NeuroPsychology (VITAL-NP) (VITAL-NP) Brianne Bettcher, University of Colorado Anschutz Medical Campus Home-based video Tele-neuropsychological assessment (TeleNP) versus a face-to-face (FF) neuropsychological assessment in older adults with suspected Alzheimer's disease or related dementias for the delivery of neuropsychological evaluations Care recipient (Ages 60 - 89) who are undergoing evaluation for possible Alzheimer's disease and whose severity ranges from mild cognitive impairment to mild dementia and their care partner 2024
Locus-coeruleus Function in Normal Elderly and AD Risk (LEAD) Locus-coeruleus Function in Normal Elderly and AD Risk (LEAD) Ricardo Osorio, New York University School of Medicine Locus coeruleus (LC) targeted imaging coupled with other biomarker testing to determine whether LC dysfunction can be measured in preclinical Alzheimer's disease stages Cognitively normal older adults (Ages 60 - 75) 2024
Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial The Brain Health Study: A Pragmatic, Patient-Centered Trial Sascha Dublin, Kaiser Foundation Hospitals - Washington Electronic health record (EHR) dementia screening tool to detect cognitive impairment Older adults enrolled in Kaiser Washington or UCSF care within the past two years with no prior diagnosis of dementia (Ages 65+) 2026
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History (PATH) Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History (PATH) Christian Lobue, University of Texas Southwestern Medical Center Mechanistic study using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools Individuals with amnestic mild cognitive impairment with and without a history of mild traumatic brain injury (TBI) 2027
Quantitative Imaging of Brain Glymphatic Function in Humans Quantitative Imaging of Brain Glymphatic Function in Humans Manus Donahue, Vanderbilt University Medical Center MRI and PET imaging to evaluate levels of beta-amyloid burden and assess lymphatic drainage function Older adults with Parkinson's disease (Ages 55 - 80) 2025
ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings Cindy Nowinski, Northwestern University Cognitive assessment toolbox to detect cognitive decline in Medicare Annual Wellness visits. Older Adults/Patients (Ages 65+) 2025
Using Routine Care Electronic Medical Record Data and Artificial Intelligence to Develop a Passive Digital Marker to Predict Postoperative Delirium TBD Sanjay Mohanty, Indiana University-Purdue University Indianapolis Test a clinical decision support tool incorporating a Passive Digital Marker (PDM) that predicts postoperative delirium based on EHR data and machine learning techniques for feasibility, acceptability, and effect size Patients scheduled for elective major abdominal surgery requiring inpatient stay of more than 24 hours (Ages 50+) 2027
Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care

Early Detection of Cognitive Decline (EDCD)

Maria Edelen, RAND Corporation Electronic health record (EHR) dementia screening tool, implemented in clinical practice to increase early detection of cognitive impairment Providers of patients (Ages 65+) 2024
A Cognitive Risk Calculator and Screening tool for Primary Care Settings TBD Darlene Floden, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University Cognitive screening tools (EHR-based Cognitive Risk Calculator and iPad-based Brief Assessment of Cognitive Health) used in primary care settings to detect dementia Providers caring for patients (Ages 60+) 2025
A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment

A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment (CI Wizard)

Leah Hanson, HealthPartners Institute Electronic health record (EHR) cognitive impairment clinical decision support tool to improve early detection and management of cognitive impairment Patients with elevated dementia risk 2025
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Healthy and Alzheimer's Diseased Brain First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia David Wilson, University of California San Francisco A novel PET imaging tracer, RP-115, to evaluate changes in astrocytes in healthy versus cognitively impaired Alzheimer's disease patients by quantitative PET imaging of the excitatory amino acid transporter 2 (EAAT2; an astrocytic glutamate transporter) Individuals with Alzheimer's disease and healthy older adults 2026

Napping, Sleep, Cognitive Decline and Risk of Alzheimers Disease

Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

Yue Leng, University of California San Francisco Cognitive behavioral therapy for insomnia (CBT=I), which incorporates cognitive, behavioral and educational components to improve cognitive outcomes Older adults with mild cognitive impariment or mild Alzheimer's disease (Ages 65+) 2024
READI-SET-GO: Researching Efficient Approaches to Delirium Identification - Sustaining Effective Translation to create Gero-friendly Organizations Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation (READI-SET-GO) Donna Fick, Pennsylvania State University Daily nurse-led delirium screening using the Ultra-brief Confusion Assessment Method in routine care among all hospitalized older adults to inform best practices for delirium identification, including in vulnerable individuals such as those with Alzheimer’s disease and related dementias Adults, including a subgroup of participants with Alzheimer’s disease and Alzheimer’s related dementia, with an expected hospital length of stay of 3 or more days (Ages 70+) 2028
Cognitive Screening Made Easy for Primary Care Providers TBD Robin Hilsabeck, University of Texas at Austin Cognitive screening tool (RACS app) for primary care providers to conduct cognitive screenings on a regular basis Cognitively normal and cognitively impaired adults (Ages 60+) 2026
Novel Methods for Clinical Trials in Dementia and Cognitive Decline TBD Donald Royall, University of Texas Health Science Center at San Antonio Donepezil, a cholinesterase inhibitor, to measure the impact on the latent dementia severity metric, and Adipokines, inflammatory proteins, to test the the effects of donepezil on the latent dementia severity metric. People with Alzheimer's disease or mild cognitive impairment (Ages 65 – 100) 2028
Leveraging Electronic Health Records for Reducing Dementia Screening Disparities in Diverse Communities TBD Narges Razavian, New York University School of Medicine Electronic health records/artificial intelligent predictive model used to improve Alzheimer’s disease and related dementias screening rates and early diagnosis and healthcare metrics related to cognitive health Primary care providers and patients at high risk for mild cognitive impairment or Alzheimer’s disease and related dementias 2028

Section 6: Treatments for Neuropsychiatric Symptoms

Non-Pharmacological
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Randomized Controlled Trial of Electroconvulsive Therapy Plus Usual Care Versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia (ECT-AD) Electroconvulsive Therapy (ECT) for Agitation in Alzheimer's Dementia (AD) Brent Forester, McLean Hospital Electroconvulsive Therapy to treat severe agitation in moderate to severe stage Alzheimer's disease People with moderate to severe stage Alzheimer's disease (Ages 55+) 2024
Methodology Issues in a Tailored Light Treatment for Persons with Dementia Methodology Issues in a Tailored Light Treatment for Persons with Dementia Mariana Figueiro, Icahn School of Medicine at Mount Sinai Light treatment designed to promote better sleep, cognition, mood and behavior in people living with Alzheimer's disease or related dementias Individuals with Alzheimer's disease or related dementias and sleep problems (Ages 65+) 2025
Problem Adaption Therapy for Mild Cognitive Impairment with Depression Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI) Dimitris Kiosses, Joan and Sanford I Weill Medical College of Cornell University Problem Adaptation Therapy (PATH), a novel psychosocial intervention designed to reduce depression and disability in older adults with major depression People with Mild Cognitive Impairment and depression (Ages 60+) 2024
Circuit-specific Neuromodulation for the Treatment of Apathy in Alzheimer's Disease TMS as a Treatment for Apathy in Alzheimer's Disease Mark Eldaief, Massachusetts General Hospital Repetitive Transcranial Magnetic Stimulation (rTMS) to modulate cortico-striatal circuits in neurodegenerative patients with apathy Alzheimer's disease participants with apathy (Ages 50 - 80) 2024
Development of Memesto, A Wearable Repetitive Message and Music Therapy Device that Senses and Reduces Agitation in Persons with AD/ADRD Memesto Wearable Device for Persons With Dementia Jeffery Banker, Edgewater Safety Systems LLC Wearable therapy device that automatically senses rising agitation and alerts caregivers, while deploying calming voice and music therapy to help avoid crisis level behavior Adults with dementia diagnosis 2023
Pharmacological
Project Name Trial Name Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Escitalopram for Agitation in Alzheimer's Disease Escitalopram for Agitation in Alzheimer's Disease (S-CitAD) Constantine Lyketsos, Johns Hopkins Bayview Medical Center Escitalopram, a small molecule selective serotonin reuptake inhibitor (SSRIs) antidepressant to treat agitation in Alzheimer's disease People with Alzheimer's disease and agitation 2024
Lifes end Benefits of CannaBidol and TetrahYdrocannabinol (LiBBY) Trial Life's End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY) Jacobo Mintzer, Medical University of South Carolina Cannabidol and Tetrahydrocannabinol, Cannabis chemotypes, to improve quality of life in adults with Alzheimer's disease Adults with Alzheimer's disease 2024
Pilot Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD) Paul Rosenberg; Brent Forester, Johns Hopkins University; McLean Hospital Dronabinol, a synthetic form of THC and partial agonist of CB1/2 endocannabinoid receptors to treat severe agitation in Alzheimer's disease People with Alzheimer's disease and agitation (Ages 60-90) 2024

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