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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 423 active clinical trials on Alzheimer’s disease and related dementias (AD/ADRD). These prevention and intervention trials reflect diverse drug and mechanistic targets, as well as diversity in the stages of AD/ADRD they address. NIA’s active trials include: early stage clinical drug development (61), late stage clinical drug development (8), non-pharmacological interventions (131), dementia care and caregiver interventions (196), and other types of trials (27), including trials for clinical therapy development for neuropsychiatric symptoms of dementia and trials for evaluating diagnostic tools. Please see the tables below for more details about these trials.*

Graph chart of NIA-funded Alzheimer's clinical trials. See below for details.
Graphic of Alzheimer's and related dementia NIA-funded trials. Click below for specific trial information.

Please note: The data in the graphics are from March 2022.

On this page:

*The data in the tables below are from March 2022

Section 1: Early Stage Clinical Drug Development (Phase I and Phase II Clinical Trials)

Amyloid
Project Name Trial Name on CT.gov 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) 2022
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 Susan Catalano, Cognition Therapeutics Inc CT1812, a small molecule sigma2 receptor antagonist that displaces Aβ oligomers bound to neuronal receptors at synapses Mild to moderate AD patients (Ages 50-80) 2022
A Single Ascending Dose / Multiple Ascending Dose Phase I study of the GSM 776890 in healthy normal subjects TBD Steven Lee Wagner, University Of California, San Diego Gamma secretase modulator (GSM)776890, an Allosteric modulator of APP processing Healthy adult participants 2023
A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Alzheimer's Disease TBD Adam Peter Mecca, Yale University BMS-984923, blocks aberrant Amyloid beta activation of mGluR5 Adults with early AD (Ages 50-80) 2024
COG0202, A Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease over 18 Months TBD Susan Catalano, Cognition Therapeutics Inc CT1812, a small molecule sigma2 receptor antagonist that displaces Aβ oligomers bound to neuronal receptors at synapses Older adults with early AD, late mild cognitive impairment, and mild AD dementia 2025
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 Aβ oligomers bound to neuronal receptors at synapses Adults with Mild to Moderate Alzheimer's Disease (Ages 50-85) 2022
Open-label extension of a 3-month blinded clinical trial of PTI-125 Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients (PTI-125) Lindsay H. Burns, Pain Therapeutics Inc PTI-125, a small molecule that targets filamin A (FLNA), a protein critical to beta amyloid's toxicity Mild to Moderate Alzheimer's Disease (Ages 50-85) 2022
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 Howard Feldman, University of California San Diego PQ 912, a small molecule glutaminyl cyclase (QC) inhibitor to treat both amyloidopathy and neuroinflammation Adults with MCI or mild probable AD (Ages 50-89) 2023
Human AME study of CT1812, a small molecule in phase 2 clinical trials for the treatment of Alzheimer's disease Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects (COG0108) Susan Catalano, Cognition Therapeutics Inc CT1812, a small molecule sigma2 receptor antagonist that displaces Aβ oligomers bound to neuronal receptors at synapses Healthy male volunteers (Ages 30 - 65) 2023
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) Susan Catalano, Cognition Therapeutics Inc CT1812, a small molecule sigma2 receptor antagonist that displaces Aβ oligomers bound to neuronal receptors at synapses Individuals with mild to moderate Lewy Body Dementia 2024
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 (PD) Older adults with PD diagnosis and no active depression (Ages 65+) 2025
Food Effect study and drug supply scale-up for PTI-125 TBD Lindsay H. Burns, Pain Therapeutics Inc PTI-125, a small molecule that targets filamin A (FLNA), a protein critical to beta amyloid's toxicity Healthy young adults 2022
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. TBD Michael Agadjanyan, Institute for Molecular Medicine AV-1959D, a DNA based vaccine targeting amyloid beta to reduce amyloid plaque Early AD participants, Ages 60 to 85 2027
Circadian Rhythm
Project Name Trial Name on CT.gov 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 regulate sleep, to improve cognition in older adults Older adults (Ages 60-75) 2024
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 University Trazadone, an antidepressant to treat sleep disturbance and improve cognitive outcomes Individuals with prodromal AD/amnestic Mild Cognitive Impairment and sleep complaints 2026
Growth Factors and Hormones
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Health of the Cholinergic System and Risk for Alzheimers Disease in Postmenopausal Women Cholinergic Health After Menopause (CHAMP) Julie A Dumas, University of Vermont & St Agric College Mecamylamine, a cholinergic antagonist, to study the relations between the cholinergic system's functional integrity, cognition, and known AD biomarkers Postmenopausal women (Ages 50-70) 2024
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 AD and/or Mild Cognitive Impairment  2026
The LUCINDA Trial The LUCINDA Trial: LUpron Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA) Tracy Butler; James Galvin; Craig Atwood, New York University School of Medicine; Florida Atlantic University; University of Wisconsin Lupron, a small molecule gonadotropin-releasing hormone (GnRH) receptor agonist to slow cognitive decline in women with mild to moderate AD Women with mild-moderate Alzheimer's Disease who are also taking AChEl (Ages 65-90) 2024
Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study) Lyndsey DuBose, University of Colorado Denver GnRH antagonist, a gonadotropin-releasing hormone antagonist Premenopausal women with lower E2 2023
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 on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimers 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 2023
First-in-Human (Phase 1) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimers Disease (AD) TBD Eti Yoles, Immunobrain Checkpoint Inc. IBC-Ab002, an antibody therapy targeting the peripheral immune system Individuals with early AD (Ages 50 - 75) 2024
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
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) Wayne Anderson, Neurokine Therapeutics, LLC 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) 2023
GM-CSF/sargramostim treatment to improve cognition in Down syndrome TBD Huntington Potter, University of Colorado Denver Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)/Sargrammostim, an immune system modulator to improve cognition Young adults with Down Syndrome 2023
Assessment of lenalidomide to treat Alzheimer's disease MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients (MCLENA-1) Marwan Sabbagh; Boris Decourt, Cleveland Clinic; Arizona State University Lenalidomide, a small molecule Anti-inflammatory immunomodulator to reduce neuroinflammation and slow or prevent AD 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 AD 2024
BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (BEACH) Daniel Hanley and Linda Van Eldik, Johns Hopkins University MW189, a small molecule that selectively suppresses injury- and disease-induced neuro- inflammation Participants with spontaneous, non-traumatic, Intracranaial Hemorrhage 2025
Metabolism and Bioenergetics
Project Name Trial Name on CT.gov 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 ild cognitive impairment (MCI) and mild Alzheimer’s disease (mild-AD) (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 T3D-959, a small molecule PPARγ and PPARδ agonist to improve cognition in AD Adults with mild to severe AD (Ages 50-90) 2023
Multi-Target
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Senolytics to Improve Cognition and Mobility in Older Adults at Risk of Alzheimer’s Disease TBD Lewis Lipsitz, Hebrew Rehabilitation Center for Aged Quercetin and Dasatinib, a senolytic combination, to improve brain blood flow Older adults with slow gate speed and Mild Cognitive Impairment (Ages 70 - 90) 2023
A Proof of Concept Trial of a Sirtuin-NAD+ Activator in Alzheimer's Disease TBD Shalender Bhasin, Brigham and Women's Hospital β nicotinamide mononucleotide (βNMN): An NAD+ precursor to slow AD progression and improve cognition Mild AD dementia participants 2024
Safety and Pharmacokinetics of JOTROL for Alzheimer's Disease JOTROL PK, Safety, and Food Effect Assessment Marshall Hayward, Jupiter Orphan Therapeutics, Inc. JOTROL, A high bioavailability orally administered form of Resveratrol - a stabilizer of Aβ40 and Aβ42 accumulation in the brain Normal healthy volunteers (Ages 18 - 75) 2022
Repurposing Siponimod for Alzheimer's Disease TBD Marwan Sabbagh, Cleveland Clinic Lerner COM-CWRU Siponimod, an immunomodulatory small molecule used to treat multiple sclerosis and serves as a neuroprotective Individuals with early AD (Ages 60-85) 2026
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 Medical Center Lithium, a GSK3α and GSK3β inhibitor to prevent or slow cognitive decline in older adults with MCI People with Mild Cognitive Impairment Age (Ages ≥60) 2022
Depression treatment and Aβ dynamics: A study of Alzheimer’s disease risk Aβ Dynamics in LLMD Nunzio Pomara, New York University School of Medicine Escitalopram Oxalate, a SSRI antidepressant to examine effects of AD biomarkers Older cognitively unimpaired adults with Major Depressive Disorder (Ages 60+) 2026
Neurogenesis
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A randomized, placebo-controlled, double-blind study to evaluate safety and efficacy of NDX-1017 treatment in Alzheimer's dementia patients A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (ACT-AD) Xue Hua, Athira Pharma, Inc NDX-1017, a small molecule hepatocyte growth factor (HGF) system agonist to reverse cognitive decline and block neurodegeneration Mild-to-moderate Alzheimer’s disease (AD) dementia patients (age 55-85 years) 2023
Other
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
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 Colorado Nicotinamide Riboside, a precursor molecule of Nicotinamide adenine dinucleotide (NAD+) to improve cerebrovascular function and improve memory in patients with MCI People with amnestic Mild Cognitive Impairment (Ages 60-90) 2023
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) 2022
Pathophysiology of postoperative delirium and the use of biomimetic sleep as a treatment strategy in the CSICU Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study (MENDING) Oluwaseun Johnson-Akeju, Massachusetts General Hospital Guanfacine, an alpha-2 agonist and FDA-approved medication for hypertension and ADHD, to reduce the incidence of delirium in hospitalized COVID-19 patients Hospitalized COVID-19 patients 2022
Metformin Effect on Brain Function in Insulin Resistant Elderly People Metformin Effect on Brain Function in Insulin Resistant Elderly People Sree Nair, Mayo Clinic Metformin, a medication with proven efficacy in decreasing hyperinsulinemia and preventing diabetes, to enhance brain mitochondrial function (ATP production) Older adults with abdominal adiposity and impaired fasting glucose (Ages 65+) 2022
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 AD and whether antiviral treatment can improve cognition People with mild Alzheimer's disease 2023
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, UT 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) 2023
Mid-Career Program for Vascular Contributions to Alzheimer's disease Candesartan's Effects on Alzheimer's Disease And Related Biomarkers (CEDAR) Ihab Hajjar, Emory University Candesartan, an angiotensin receptor blocker (blood pressure medication) that may reduce neuro-vascular injury Adults (Ages 50+) 2025
The Use of Deferiprone to Improve Subarachnoid Hemorrhage Cognitive Outcome: U-DISCO Deferiprone for Ruptured Brain Aneurysm David M Hasan, University of Iowa Deferiprone to improve cognitive outcomes Adults with aneurysmal subarachnoid hemorrhage at risk for cognitive decline (Ages 18 - 70) 2025
Oxidative Stress
Project Name Trial Name on CT.gov 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 Sekhar Rajagopal Viswanath, Baylor College of Medicine Glutathione supplementation to improve cognition in AD Adults with MCI (Ages 65-80) 2023
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease Glutathione and Alzheimer's Disease Rajagopal Viswanath Sekhar, Baylor College of Medicine Glutathione supplementation to improve cognition in AD Mild cognitive impairment (MCI) and mild Alzheimer’s disease (mild-AD) subjects (Ages 55-85) 2025
Receptors
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
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 TBD Jan Johansson, Artery Therapeutics, Inc. CS6253, an ABCA1 transporter agonist to treat APOE4 associated dementia Healthy young adults 2022
Silent Allosteric Modulation of mGluR5 for Safe and Effective Therapy of Alzheimer's Disease Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923 Stephen Strittmatter, Yale University BMS-984923, a novel disease-modifying compound for Alzheimer's disease (AD). Cognitively healthy older adults (Ages 50-80) 2023
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 AD Healthy adult carriers and non-carriers of APOE ε4 (Ages 60-80) 2023
Long Term Nicotine Treatment of Mild Cognitive Impairment Memory Improvement Through Nicotine Dosing (MIND) Study (MIND) Paul Newhouse; Paul Aisen, Vanderbilt University; Alzheimer's Therapeutic Research Institute Nicotine to improve cognition in AD People with Mild Cognitive Impairment (Ages ≥55) 2023
Cognitive, urinary, and functional trajectories of older women using pharmacologic treatment strategies for urgency incontinence TBD Alison Huang, University of California, San Francisco Tolterodine and Mirabegron, anticholinergic bladder medications Older women with urinary incontinence and without pre-existing dementia 2027
Synaptic Plasticity
Project Name Trial Name on CT.gov 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 AD (Ages 70-82) 2024
Treating hyperexcitability in Alzheimer’s disease with levetiracetam to improve brain function and cognition Treating Hyperexcitability in AD With Levetiracetam Mouhsin Shafi, Harvard Levetiracetam, a small molecule synaptic vesicle protein (SV2A) modulator, to improve cognition in AD Adults with probable AD (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 LBD with both dementia and Parkinsonism (Ages 25-90) 2023
Long-term therapeutic effects of synthetic bryostatin-1 in advanced AD without memantine Bryostatin Treatment of Moderately Severe Alzheimer's Disease Miao-Kun Sun, Neurotrope Bioscience Inc Bryostatin-1 , a small molecule activator of PKCε in the hippocampus to restore synaptic function and improve cognition in advanced AD Adults with advanced AD (Ages 55-85) 2023
Allopregnanolone as Regenerative Therapeutic for Alzheimer's: Phase 2 Clinical Trial Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease (REGEN-BRAIN©) Roberta Diaz Brinton; Kathleen E. Rodgers; Lon S. Schneider, University of Arizona; University of Southern California Allopregnanolone, a small molecule that stimulates anti-inflammatory mechanisms and mitochondrial function to regenerate neurons and restore cognition in AD Adults who are APOEe4 positive and diagnosed with mild AD (Ages ≥ 55) 2025
Vasculature
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A biomarker-driven trial of angiotensin receptor blockers for prodromal Alzheimer Candesartan's Effects on Alzheimer's Disease And Related Biomarkers (CEDAR) Ihab Hajjar, Emory University Candesartan, a small molecule angiotensin II receptor blocker to improve vascular and neurological markers in AD Non-hypertensive adults with Mild Cognitive Impairment (Ages ≥40) 2022
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 A. Jicha; Peter Nelson, 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) 2024
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
Arterial Stiffness, Cognition, and Equol (ACE) TBD Akira Sekikawa, University of Pittsburgh at Pittsburgh Equol supplementation as an intervention to improve cognitive decline by targeting arterial stiffness and white matter lesions in the brain Older adults aged 65+ 2027

Section 2: Late Stage Clinical Drug Development (Phase II/III, III, and IV Clinical and Pragmatic Trials)

Amyloid
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Alzheimer's Prevention Initiative Autosomal Dominant Alzheimer's Disease Colombia Trial A Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers to Evaluate Efficacy and Safety in the Treatment of Autosomal-Dominant Alzheimer's Disease (AD), Including a Placebo-Treated Non-Carrier Cohort Eric Reiman; Pierre Tariot; Francisco Lopera, Banner Health; Universidad De Antioquia Crenezumab, an anti-amyloid β antibody to reduce amyloid plaques and slow cognitive decline in autosomal dominant AD Cognitively healthy adults who are Alzheimer's disease genetic mutation carriers  (Ages 30 to 60) 2023
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, Brigham And Women's Hospital BAN2401 , anti-amyloidβ antibody to prevent cognitive decline in AD 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 ε4 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-amyloidβ antibody to prevent cognitive decline associated with early AD 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-amyloidβ antibody to slow or prevent cognitive decline in  cognitively normal preclinical AD participants Cognitively healthy older adults with "elevated" amyloid levels on screening PET. (Ages 55–80. Adults 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 Aβ oligomer formation Individuals with APOE4/4 and early AD diagnosis 2025
Metabolism and Bioenergetics
Project Name Trial Name on CT.gov 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 Health Sciences 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) 2024
Synaptic Plasticity
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Phase 3 Pivotal Trial of AGB101 to Slow Progression in MCI due to Alzheimer's Disease Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (Hope4MCI) Richard Charles Mohs, Agenebio, Inc. AGB101 (levetiracetam), a small molecule synaptic vesicle protein (SV2A) modulator, to slow progression of amnestic MCI due to AD Adults with amnestic Mild Cognitive Impairment (Ages 55-85) 2023
Tau
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
DIAN-TU: Tau Next Generation Prevention Trial 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 Anti-tau therapy to prevent AD Cognitively healthy or mildly impaired adults who are Alzheimer's disease genetic mutation carriers 2025

Section 3: Non-pharmacological Interventions

Cognitive Training
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
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
Mindfulness Matters: TheImpact of Mindfulness Based Stress Reduction on Post-Stroke Cognition Mindfulness Based Stress Reduction and Post-Stroke Cognition Elisabeth Breese Marsh, Johns Hopkins University Mindfulness training to reduce post-stroke cognitive impairment Adults presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission) and evidence on brain MRI of acute ischemic stroke (imaging negative strokes and TIAs will be excluded) (Ages ≥18 years) 2022
Better memory with literacy acquisition later in life: a randomized controlled trial Better memory with literacy acquisition later in life: a randomized controlled trial Lea Tenenholz Grinberg, University Of California, San Francisco Education program to improve episodic memory and enhance hippocampal connectivity Illiterate adults of any gender, with availability to participate in literacy training for at least 6 months (Ages 40 - 89) 2022
Understanding Individual Differences in Working Memory Training and Transfer in Older Adults at Risk of Alzheimer's Disease and Related Dementias TBD 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 AD/DRD 2022
Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE) Thomas Vanvleet; 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+) 2022
Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia The Active Mind Trial Jerri Edwards, University of South Florida Combination of cognitive training exercises to modify the functional trajectories of adults with MCI Adults (Ages 65-89) 2022
Elucidating the Necessary Components and Mechanisms of Cognitive Training TBD Lesley A 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) 2022
Cognitive training and neuroplasticity in mild cognitive impairment Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining) Davangere P. Devanand, Columbia University Computerized cognitive training to improve cognitive performance People with Mild Cognitive Impairment (Ages 55-95) 2023
Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia Emily Rogalski, Northwestern University Personalized speech-language therapy intervention Individuals with Mild Primary Progressive Aphasia (Ages ≥30) 2023
A Scalable Model for Promoting Functioning and Well-Being among Older Adults with Mild Cognitive Impairment via Meaningful Social Interactions: Project SPEAK! A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK! John D Piette, University of Michigan at Ann Arbor A videoconference program to engage older adults with English Language Learners to improve well being and cognitive function Older adults reporting loneliness on a validated measure (Ages 55+) 2023
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 Sunghoon Lee and Jean Daneault, University of Massachusetts Amherst and Rutgeres University Serious games (Neuro-World), to stimulate working memory and improve cognition Older adults with Mild Cognitive Impairment 2023
Develop an ANS-based Personalized Cognitive Training for Mild Cognitive Impairment TBD Feng Vankee Lin, Stanford University Speed of processing training (SOPT), a computerized cognitive training task to improve cognitive health Adults with Mild Cognitive Impairment (Ages 60-89) 2023
Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Telerehabilitation Alzheimer's Disease Feasibility (TADF) Grigore C. Burdea, Bright Cloud International Corporation BrightGo, a home-based custom Virtual Reality system involving therapeutic games aimed primarily at the memory cognitive domain People with mild Alzheimer’s disease (Ages ≥ 65) 2023
Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Telerehabilitation Alzheimer's Disease Usability (TADU) Grigore C. Burdea, Bright Cloud International Corporation BrightGo, a home-based custom Virtual Reality system involving therapeutic games aimed primarily at the memory cognitive domain People with mild Alzheimer’s disease (Ages ≥ 65) 2023
Feasibility of the Memory and Attention Adaptation Training-Geriatrics Intervention in Older Cancer Survivors with Mild Cognitive Impairment 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 Richard 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 at Saint Louis Memory encoding strategies to improve prospective memory Adults who meet criteria for typical idiopathic PD (Ages 50+) 2025
Early Cognitive Training and Rehabilitation to Prevent Cognitive Decline in Older Hospitalized Adults with Delirium Early Cognitive Intervention in Delirium Jin Ho Han, Vanderbilt University Medical Center Cognitive training rehabilitation program for individuals with delirium to improve working memory Older delirious patients with and without ADRD 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
Promoting Independence with Compensatory Cognitive Rehabilitation: A Pilot Clinical Trial for Early-Stage Alzheimer's Disease Promoting Independence With Compensatory Cognitive Rehabilitation Alyssa Marie Lanzi, University of Delaware A behavioral treatment (Structured External Memory Aid Treatment (SEMAT) to promote independent living skills Adults with MCI (Ages 65 - 85) 2026
Cognitive training to reduce incidence of cognitive impairment in older adults Preventing Alzheimer's Disease with Cognitive Training Jerri Edwards, University of South Florida Speed of processing training intervention to reduce incidence of MCI or dementia Older adults who are cognitively normal 2026
Modulation of Hippocampal Circuitry and Memory Function with Focused Ultrasound in Amnestic MCI TBD Susan Bookheime, University of California Los Angeles Low intensity focused ultrasound pulsation (LIFUP) to improve learning and memory Adults (Ages ≥ 75) 2026
Combination Therapy
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Exercise and Intensive Vascular Risk Reduction in Preventing Dementia Risk Reduction for Alzheimer's Disease (rrAD) Rong Zhang; Ellen Binder;  Jeffrey Burns;  Munro Cullum;  Jeffrey Keller; Diana Kerwin,  UT Southwestern Medical Center; Washington University; University of Kansas Medical Center; UT Southwestern Medical Center; Pennington Biomedical Research Center; Texas Health Presbyterian Hospital Dallas Aerobic exercise intervention coupled with Atorvastatin to determine the independent and combined effects of on neurocognitive function Cognitively healthy older adults (Age ≥65) 2022
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,  University of Minnesota 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) 2022
Multidomain Alzheimer's Risk Reduction Study (MARRS) Pilot Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT) Kristine Yaffe;  Eric Larson,  University of California San Francisco; Group Health Research Institute Multi-domain therapy (cardiovascular risk management; smoking cessation; physical, mental and social activity; healthy diet; improved sleep quality and medication management) to reduce AD risk Individuals with subjective cognitive complaints (Ages ≥70) 2022
A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions Pariya Fazeli Wheeler,  University of Alabama, Birmingham  CogRx, a combination therapy to address deficiencies in physical activity, cognitive activity, diet, sleep, and social activity, and their impacts on cognition African-Americans (Ages 50-65) 2022
MIND Food and Speed of Processing Training in Older Adults with Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial MINDSpeed Food and Brain Training RCT (MINDSpeed) Daniel O. Clark,  Indiana University Nutrition intervention (with foods high in polyphenols) combined with cognitive training exercises to test impact on cognitive performance  Older adults (60+) 2023
Augmenting Cognitive Training in Older Adults - The ACT Grant Augmenting Cognitive Training in Older Adults (ACT) Adam Woods,  University of Florida Neurostimulation (tDCS) combined with cognitive training program to slow cognitive decline Adults with age-related cog. Decline (Ages 65 - 89) 2023
Decreasing Alzheimer's Disease and Related Dementias after Delirium-Exercise and Cognitive Training (DDD-ECT) Improving the Recovery and Outcome Every Day After the ICU (IMPROVE) Babar Khan,  Indiana University Physical and cognitive exercise programs to improve cognitive functioning of older adults who experience an episode of delirium while hospitalized in an intensive care unit Adults with history of delirium (Ages 65+) 2023
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 Inc 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) 2023
TeleExergame: An Interactive Tele-Rehabilitation Platform for Improving Motor Function in Older Adults with Cognitive Deficit TBD Ashkan Vaziri, Biosensics, LLC 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 2023
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; John P. Arciero; Paul J. Arciero; Mina Dunnam; David Arthur Merrill; Stella E. Panos; Emilie Saulnier,  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) 2023
Targeted physical and cognitive activity in a VR environment in older adults at risk for Alzheimer's disease  TBD Judy Pa,  University of Southern California Physical and cognitive activity program in a virtual reality environment to improve cognition People with early Mild Cognitive Impairment (Ages 55-80) 2025
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 of Louisiana Multifaceted intensive blood pressure intervention Racial minority and low-income hypertensive patients 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
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 MOCA less than 26 out of 30 will be classified as mild cognitive impairment and those above 26 out of 30 as cognitively intact older adults (Ages 55+) 2026
Diet and Supplements
Project Name Trial Name on CT.gov 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 TBD Susan Roberts and Maria Franceschini, Tufts University and Harvard University Nutrition-based intervention to improve cognitive and brain functioning Older adults who are overweight/ obese 2022
MIND Diet Intervention to Prevent Alzheimer's Disease MIND Diet Intervention and Cognitive Decline (MIND) Martha Clare Morris, Rush University Combination Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diet to measure effect on cognition Cognitively health older adults (Ages 65-84) 2023
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) 2023
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) 2023
Dietary Modulation Of Neuroinflammation In Age-Related Memory Disorders Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders Richard Sloan, New York State Psychiatric Institute Cocoa-flavanol supplement to reduce systemic inflammation, improve cerebral blood volume to the hippocampus, and improve cognition Adults (Ages 50-69) 2023
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+) 2023
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 AD participants People with Alzheimer's Disease Ages 50-90) 2024
Brain Healthy Soul Food Diet Intervention Among Older African Americans TBD Ashley Shaw, University of Kansas Medical Center Culturally adapted, brain-healthy diet Older African Americans (Ages 55+) 2025
MIND DIET AND DEMENTIA PREVENTION IN ISCHEMIC STROKE PATIENTS Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients Neelum T 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) 2025
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 High fat drink (heavy dairy cream) Older adults with and without APOE E4 (Ages 55+) 2025
Exercise
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Genes, Exercise, Neurocognitive and Neurodegeneration: Community–Based Approach Genes, Exercise, Neurocognitive and Neurodegeneration: Community-Based Approach (GEMSII) Thomas Obisesan, Howard University Aerobic exercise training program vs. stretch-exercise program to measure cognitive performance and neurodegeneration in African-Americans People with Mild Cognitive Impairment (Ages 55–85) 2022
Effects of physical activity on brain function and network connectivity in MCI Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study Arthur Toga, University of Southern California Home-based moderate-aerobic walking program Older adults without dementia (Ages 55-80) 2022
Investigating Gains in Neurocognition in an Intervention Trial of Exercise Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) Kirk Erickson; Jeffrey Burns; Edward Mcauley; Arthur Kramer, University of Pittsburgh; University of Kansas; University of Illinois Urbana-Champaign; Northeastern University Exercise program to decrease cognitive decline associated with aging Sedentary adults 65 to 80 2022
Dementia Risk and Dynamic Response to Exercise Dementia Risk and Dynamic Response to Exercise Eric Vidoni, University of Kansas Medical Center Aerobic exercise Older adults (Ages 65-85) 2022
A Mobile Tai Chi Platform for Fall Prevention in Older Adults TBD Paolo Bonato, Biosensics, LLC Tai Chi intervention, to assess the impact of the multimodal exercise on combined physical and cognitive function Older adults with mild cognitive impairment (Ages 65-86) 2022
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) 2023
Exercise for Brain Health with Increased Genetic Risk for Alzheimer's Disease Exercise for Brain Health in the Fight Against Alzheimer's Disease Jerome Carson Smith, University of Maryland Exercise and flexibility training programs to improve quality of life and physical function Physically inactive adults (Ages 60 - 80) 2023
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-measured by determining viscoelastic properties through magnetic resonance elastography (MRE), changes during aging, in both normal and cognitively impaired individuals, and in response to 3 months of exercise therapy Healthy participants and participants with amnestic Mild Cognitive Impairment (Ages 65+) 2023
The effect of physical activity on cognition relative to APOE genotype (PAAD-II) The Effect of Physical Activity on Cognition Relative to APOE Genotype (PAAD-2) Jennifer Etnier, University of North Carolina Greensboro Physical Activity program intervention to delay the onset of AD Adults with a family history of Alzheimer's Disease (Ages 40-65) 2023
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) 2023
Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Robert Newton; Owen Carmichael, Pennington Biomedical Research Center Aerobic exercise & strength training programs to promote cognitive function in older African American adults African Americans (Ages 65-85) 2023
FitMi AD: a safe and motivating computer-guided exercise system for individuals with MCI or mild dementia due to Alzheimer's disease TBD Daniel Zondervan, Flint Rehabilitation Devices FitMi AD system, a wireless, sensorized at-home exercise device Individuals with MCI or mild dementia 2023
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 (MCI) 2023
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 MCI 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 E. 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 AD (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 Taylor Ptomey, University of Kansas Medical Center Research Institute Moderate-to-vigorous physical activity in adults with down syndrome to prevent AD 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 Gloria Adriana Perez, University of Pennsylvania "Tiempo Juntos para la Salud," a multilevel intervention for Latinos with MCI including empowerment education for behavior change and individual motivation, building support network, and promoting community resources for safe walking to reduce inactivity, a factor for AD/ADRD Spanish language dominant Latinos with MCI (Ages 55+) 2024
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 2025
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 Kathleen Morris, University of Kansas 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 M. Rao; Jay Alberts, Cleveland Clinic Lerner Com-CWRU Indoor Cycling (high intensity; 60-90% of heart rate reserve) to slow or delay disease onset Healthy elders at genetic risk for AD; APOE ε4 carriers (Ages 65-80) 2025
Natives Engaged in Alzheimer's Research: IKE Kupuna (Elder Wisdom) Project TBD Buchwald, Galvin, Kauwe, Washington State Universtiy  A tailored Hula dance program to prevent or slow cognitive decline Older Native Hawaiians Pacific Islanders with uncontrolled hypertension (Ages 55+) 2026
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 Lee Newton, LSU Pennington Biomedical Research Center Exercise intervention to reduce risk in African Americans with Mild Cognitive Impairment African Americans with MCI (Ages 65-85) 2026
Differential Effects of Exercise Modality on Cognition and Brain in Older Adults Combined Exercise Trial (COMET) Eric Dennis 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
Objectively Measured Sedentary Behavior and Physical Activity in PREVENTABLE Study TBD Srinivasan Beddhu, University of Utah An exercise trial to test sedentary behavior vs. physical activity levels on prevention of ADRD Adults (Ages 50-90) 2026
Neurostimulation
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Noninvasive Cortical Stimulation to Improve Memory in Mild Cognitive Impairment Noninvasive Brain Stimulation for Mild Cognitive Impairment Joy Taylor, Stanford Repetitive Transcranial Magnetic Stimulation (rTMS) to improve memory in participants with Mild Cognitive Impairment People with Mild Cognitive Impairment (Ages ≥55) 2022
Treatment of mild cognitive impairment with transcutaneous vagal nerve stimulation Treatment of Mild Cognitive Impairment With Transcutaneous Vagal Nerve Stimulation (TVNS MCI) John Williamson, University of Florida Transcutaneous vagal nerve stimulation (tVNS) to improve cognition and quality of life People with amnestic MCI (Ages 60-89) 2022
Cholinergic functions and modulation of the cingulo-opercular alertness network in LBD Stimulation of Cingulao-opercular Alertness Network (SCAN) Nicolaas Ida Bohnen; Benjamin Michael Hampstead, University of Michigan at Ann Arbor Transcranial direct current neurostimulation (tDCS) to test whether tDCS to these brain regions may be relevant to manage future fluctuations in alertness in people with Lewy body dementias. Adults with Lewy Body Dementia 2022
Treating mild cognitive impairment with transcranial direct current stimulation Stimulation to Improve Memory (STIM) Benjamin Michael Hampstead, University of Michigan at Ann Arbor Transcranial direct current stimulation (tDCS) to treat MCI People with Mild Cognitive Impairment (Ages ≥65) 2023
Treating mild cognitive impairment with transcranial direct current stimulation STIM+: PET Biomarker Education & Disclosure (STIM+) Benjamin Michael Hampstead, University of Michigan at Ann Arbor Transcranial direct current stimulation Older adults with MCI 2023
Gamma Induction for Amyloid Clearance in Alzheimer's Disease Gamma Induction for Alzheimer's Disease Emiliano Santarnecchi,  Beth Israel Deaconess Medical Center Transcranial Alternating Current Stimulation (tACS) to induce increase in gamma oscillations, and assess acute and long-lasting changes in Aβ and p-tau levels via PET imaging to investigate the clinical, neurophysiological and cognitive impact Adults with mild to moderate AD (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 To investigate the effects of high density transcranial direct stimulation (tDCS) of the left frontal lobe on network and language function in participants with primary progressive aphasia (PPA), with the goal of developing a potential treatment and further understanding networks in PPA and the effect of tDCS on these networks. Adults with either nonfluent/agrammatic PPA or logopenic variant PPA (Ages 45-80) 2024
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 C. 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 Dawn Bowers; Adam Woods; Gene Alexander, University of Florida Infrared stimulation to assess improvements in cognition function and network connectivity Older adults with subjective cognitive complains and family history of AD (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; Helena Knotkova, 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 AD (Ages ≥ 60) 2025
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Dan Vlad Iosifescu; Paolo Cassano; Ricardo Osorio, New York University School of Medicine; Harvard University 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 A. Suthana; Andrew Leuchter, University of California, Los Angeles Theta burst transcranial magnetic stimulation is a non-invasive neuromodulation method that shows promise for improving memory and may be applied to brain areas that are functionally connected to the hippocampus in order to 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 University Transcranial direct current neurostimulation (tDCS) to improve clinical symptoms of MCI People with probable AD (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 Irma Jacobs, Massachusetts General Hospital Transcutaneous vagus nerve stimulation (tVNS) to improve cognitive function At-risk older adults (Ages 60-85) 2026
Other
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Multimodal Musical Stimulation for Healthy Neurocognitive Aging TBD Psyche Loui, Northeastren 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. Sham control involves the same procedures but without gamma stimulation. Neurologically healthy older and younger adults 2024
Addressing the chronic pain-early cognitive decline comorbidity among older adults; The Active Brains study TBD Ana-Maria Vranceanu, Massachusetts General Hospital Active Brains-Digital (AB-D; the Active Brains-Fitbit program simplified by replacing the hip ActiGraph + Fitbit with a wrist ActiGraph) vs Health Enhancement Program (HEP), both delivered via live video to 260 older adults with CP-ECD. Older adults with nonmalignant chronic pain (>=3 months) and early cognitive decline 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; Mary Sano,  Icahn School of Medicine at Mount Sinai Hyperbaric oxygen therapy intervention to improve cognitive function and increase cerebral blood flow and glucose utilization in MCI participants People with Mild Cognitive Impairment and diabetes (Ages ≥65) 2022
Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Frank Lin; Josef Coresh, Johns Hopkins University Hearing aid intervention to test effects on cognition Adults (Ages 70-84) 2022
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment Renee Needham Stapleton; Dale Murray,  Healthy Design Ltd. Co. An arm restraint device to increase upper extremity mobility Adults who are hospitalized and mechanically ventilated (Ages 65+) 2022
Healthy Aging: an EEG-based wearable device to accurately monitor sleep and enhance quality for improved cognitive functioning  TBD Giovanni Santostasi,  Deepwater Technologies, INC. EEG-based wearable headband to enhance cognition Cognitively healthy and adults with MCI (Ages ≥ 60) 2022
Conversational engagement as a means to delay onset AD: Phase II Internet-based Conversational Engagement Clinical Trial (I-CONECT) Hiroko Dodge, Oregon Health & Science University Conversation-based social interaction in socially-isolated adults to prevent onset of AD Cognitively healthy older adults (Ages ≥75) 2023
Mindfulness Training For Mitigating Age-Related Cognitive Decline In The Elderly Mind-body Interventions for Healthy Aging (HealthyAgers) Ruchika Prakash, Ohio State University Mindfulness-based cognitive training to prevent or mitigate age-related cognitive decline 65-85 year old, RH healthy older adults 2023
Web-enabled social interaction to delay cognitive decline among seniors with MCI: Phase I Internet-based Conversational Engagement Clinical Trial (I-CONECT) Hiroko Dodge, Oregon Health & Science University Conversation-based, web-focused social interaction to delay cognitive decline in elderly with MCI People with Mild Cognitive Impairment (Ages ≥75) 2023
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimers Disease (AD) Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease Sumeet Seth, Evon Medics, LLC 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 AD (Ages 65-85) 2023
Following the Sound of Music - Comparing the Effects of Music vs. Non-Music Based Interventions on Auditory and Cognitive Processing in Older Adults TBD Susanne Madlaina Jaeggi, University of California- Irvine Music-based intervention to improve speech ability Older adults at risk to develop AD/ADRD 2023
Impact of Music Improvisation Training on Brain Function and Cognition among Older Adults TBD Julene K Johnson, University of California, San Francisco Music improvisation intervention to promote improvements in self-regulation and facilitate late-life engagement in cognitively challenging activities Older adults with and without mild cognitive impairment 2023
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 J. Holden, Indiana University-Purdue University at Indianapolis 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 L. 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 AD will be given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history 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 reduce risk of AD Normal healthy volunteers with a family history of AD 2024
Association of Perceived Stress and Cognition TBD 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 MCI 2025
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; Jessica Mozersky, Washington University 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 David M Hasan, University Of Iowa Stenting or hybrid carotid endartarectomy intervention, to determine the cognitive outcomes associated with endovascular balloon angioplasty Inclusion criteria: 1) Age ≥ 21 and ≤ 70 years, 2) complete occlusion of cervical ICA on imaging studies (MRA or CTA) and confirmed with DSA, 3) History of TIA or stroke within 120 days of enrollment, 4) evidence of large penumbra on CTP, 5) all occlusion is due to atherosclerotic disease, and 6) a MoCA < 26 2025
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 (DM)-Specific Behavioral Activation (DM-BA) to prevent decline in verbal memory in African-Americans with amnestic multiple-domain MCI African-Americans with amnestic MCI and poorly controlled DM (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 E. Tomaszewski-Farias; Maureen Schmitter-Edgecombre, University of California at Davis Digital Memory Notebook intervention, an interactive application used to facilitate behavioral change and enhanced motivation People with AD or mild cognitive impairment (Ages 65-90) 2025
ADRD Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers Older Smoker Motivational Intervention Adrienne L 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 University Vestibular therapy to reduce falls and improve balance in older adults with mild to moderate AD and vestibular loss. Adults with mild-moderate AD & vestibular loss (Ages 60+) 2026
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 and Manney Carrington Reid,  Cornell University Problem Adaptation Therapy for Pain (PATH-Pain) primary-care based psychosocial intervention designed to reduce stress Adults with MCI or early stage AD (Ages ≥ 60) 2026
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, Breno Diniz, Julie Wetherell, Washington University 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 Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease TBD Cynthia Ann Munro, Johns Hopkins University Response to an acute stressor, (trier social stress test) in MCI Adults with MCI 2027
Characterizing and modulating neurocognitive processes of learning to trust and distrust in aging TBD Natalie Ebner, University of Florida Neurofeedback training using real time fMRI to increase activity in the anterior cingulate gyrus to improve learning. Individuals ranging in age from 20-85 yrs  2027
Sleep-related
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Changing the Trajectory of Mild Cognitive Impairment with CPAP Treatment of Obstructive Sleep Apnea MCI: CPAP Treatment of OSA (Memories2) (MCI:OSA) Nalaka Gooneratne, University of Pennsylvania Continuous positive airway pressure (CPAP) to treat people with obstructive sleep apnea in order to improve mild cognitive impairment People with obstructive sleep apnea and amnestic Mild Cognitive Impairment (Ages 55-75) 2022
A Novel Couples-Based Sleep Health Intervention For Older Adults With Obstructive Sleep Apnea: Implications for Alzheimer's Disease Risk And Healthy Aging We-PAP: A Couples-based Intervention for Sleep Apnea (We-PAP) Kelly Baron, University of Utah Couples-based sleep health education intervention to improve adherence to CPAP and improve couples' sleep experience Older adults with obstructive sleep apnea (Ages 50-85) 2022
Device to control circadian-effective light in Alzheimer's disease environments TBD Erik Page, Blue Iris Labs, Inc. Daysimeter, a calibrated light meter that measures circadian light and circadian stimulus, to measure and optimize lighting to improve sleep and mood Individuals with AD 2022
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's 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 Impairment or mild AD (Ages 65+) 2023
Light, metabolic syndrome and Alzheimer’s disease: a non-pharmacological approach Light and the Effect on Metabolic Syndrome and Alzheimer's Disease Mariana G Figueiro, Rensselaer Polytechnic Institute 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+)  2023
Understanding circadian responses to light in persons with Mild Cognitive Impairment and Alzheimer's disease TBD Mariana Figueiro, Icahn School of Medicine at Mount Sinai Lighting interventions to suppress melatonin and promote better sleep and cognition Older adults with MCI 2023
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, LLC Internet of Things (IoT) devices, such as the FitBit, Apple Watch, and Oura Ring, to improve sleep and reduce MCI 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 Cognitive behavioral therapy for insomnia (CBT-I) 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
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 Sara Carole Mednick; Mariana Figueiro, Icahn School of Medicine at Mount Sinai Light intervention to improve sleep and MCI People with Amnestic Mild Cognitive Impairment or mild AD (Ages ≥ 65) 2024
POINTER-zzz: Sleep Ancillary to U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk of Alzheimer's Disease TBD Kathleen M. Hayden; Laura D. Baker,  Wake Forest University Health Sciences In-home objective sleep assessments to examine the effects of lifestyle modification and cardiovascular risk management on sleep disturbances that have been linked to cognitive decline and AD Adults who are vulnerable to AD (Ages 60-79) 2024
The Impact of Sex Hormones on Sleep-Dependent Memory in Young and Midlife Men and Women TBD Fiona C Baker; Sara Carole Mednick,  SRI International Sound-stimulation sleep therapy to improve sleep quality and memory function in the context of the menopausal transition, supplemented with comprehensive evaluations of sex-hormone levels, sleep measures, and cognitive tasks 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 (UCSD) Supplemental oxygen and Continuous Positive Airway Pressure (CPAP) machine 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 Ann Wilckens, University of Pittsburgh at 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) TBD Mariana Figueiro, Icahn School of Medicine at Mount Sinai Rhythmic Light Therapy to improve sleep and cognition Older adults with MCI 2026

Section 4: Dementia Care and Caregiver Interventions

Advance Directives/Care Planning
Project Name Trial Name on CT.gov 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 AD)-surrogate dyads (Ages 18+) 2023
Pragmatic Trial to Improve Communication for Primary Care Patients with ADRD Improving Communication for Primary Care Patients Jennifer L Wolff, Johns Hopkins University 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 AD/ADRD (65+) 2023
POST Facilitation for Community Dwelling Older Adults with and without Dementia POST Facilitation for Community Dwelling Older Adults (POST-RCT) Alexia Mary Torke, Indiana University-Purdue University at 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 Jennier L Wolff, Johns Hopkins University 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 A Lindquist, Northwestern University at Chicago 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 TBD Hillary Lum, University of Colorado, Denver ENgaging in Advance Care planning Talks (ENACT) Group Visits intervention to increase advance care planning (ACP) documentation (one aspect of ACP) 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 Lynn Gabbard, Wake Forest University Health Sciences ACPdSmart is a dementia-specific portal-based tool for advance care planning engagement ≥65 years old with recognized or probable MCI or mild dementia, yet retain decisional capacity to complete ACP. 2027
Caregiver Assessments, Tools, Training, and Education
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
The PorchLight Project TBD Gaugler, Joseph E, University of Minnesota 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. 171 family caregivers, 171 persons with dementia and dementia; 171 senior volunteers 2027
Cognitive training to protect immune systems of older caregivers Cognitive Training for Older Caregivers (CTC) Kathi L Heffner, University of Rochester Computerized cognitive training to improve fluid cognitive abilities including processing speed and attention Older caregivers of a family member with Alzheimer's Disease (AD) or AD-related dementia (ADRD)  (Ages 60-80) 2022
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 W Hepburn, Emory University Web-based system to train interventionists on Savvy Caregiver, a dementia family caregiver psychoeducation program Dementia family caregivers (Ages 18+) 2022
The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers The Senior Companion Program Plus (SCP Plus) Noelle Fields, University of Texas, Arlington Senior Companion Program Plus (SCP Plus), an in-home psychoeducational intervention African-American caregivers for older adults with ADRD (Ages 55+) 2022
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE) Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE) Richard Holden, Indiana University-Purdue University at Indianapolis Brain CareNotes, a mobile health technology which offers support, assessment and longitudinal tracking of patient symptoms and caregiver burden including caregiving toolkit and bidirectional messaging with clinicians Dyads (Ages 65+) 2022
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, 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 2023
The Caregiver Resource Room: Enhancing Support for Caregivers of Alzheimer's Disease and Related Dementias (ADRD) TBD Francesca Falzarano, Weill Medical College of Cornell University Online self-assessment and tailored referral platform to support ADRD caregivers ADRD caregivers 2023
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+) 2023
GamePlan4Care: Web-based Delivery System for REACH II GamePlan4Care: Online Support for Family Caregivers (GP4C) Alan B Stevens, Baylor Research Institute GamePlan4Care (GP4C), an internet-based system designed to provide immediate, tailored education and skills training to caregivers Dementia caregivers (Ages 18+) 2023
Hospital GamePlan4Care: Randomized Controlled Trial - Study 3 TBD Alan B Stevens, Baylor Research Institute Hospital GamePlan4Care Caregivers of veterans with ADRD admitted to the inpatient general medicine service at MEDVAMC 2023
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: A pilot evaluation of Learning Skills Together: A intervention to teach complex care skills to caregivers of persons living with Alzheimer’s Disease (Pilot) Learning Skills Together Pilot Study Ken Hepburn, Carole White, Emory University, UT Health San Antonio intervention to test a group training program, Learning Skills Together (LST), to teach complex skills to caregivers of persons living with AD/ADRD Caregivers of persons living with AD/ADRD 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Creating Harmony at HOME: A pilot study of a telehealth-based program for rural caregivers’ ability to adapt home environments for adults with Alzheimer’s Disease and Related Disorders (ADRD) (Pilot) Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers Ken Hepburn, Emory University Harmony at HOME, a telehealth-based intervention to develop and enhance caregiver competence related to home environment adaptation to promote functional behaviors for the person with dementia Caregivers of persons living with AD/ADRD 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia (Pilot) Learning to PERSEVERE: Peer Mentor Support and Caregiver Education in Lewy Body Dementia Ken Hepburn, Jori Fleisher, Emory University, Rush University Medical Center PERSEVERE, a peer mentor support and caregiver education intervention to improve Lewy Body Dementia (LBD)-specific caregiving mastery nonprofessional caregivers of community-dwelling patients with Lewy Body Dementia (LBD) 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course (Supplement) Caregiving During Crisis Ken Hepburn, Carolyn Clevenger, Emory University Online, self-paced, psychoeducation course for family caregivers of community-dwelling PWD to improve caregiver mastery during COVID-19 Family caregivers of community-dwelling persons living with Alzheimer's and other dementing illnesses 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 Ken Hepburn, Darby Morhardt, Emory University, 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
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Producing a Fully Asynchronous Online Tele-Savvy Program (Pilot) Producing a Fully Asynchronous Online Savvy Program Ken Hepburn, Fayron Epps, Emory University Fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who care for persons living with AD/ADRD Family and friends who care for persons living with AD/ADRD 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: Stage 1 Pilot Intervention to Facilitate Caregiver Master Among LGB Caregivers of PLWD (Pilot) Equality in Caregiving (EIC) Ken Hepburn, Whitney Wharton, Emory University An LGB-focused caregiver intervention program to assess the stressors and unique needs of LGB caregivers of persons living with dementia Self identified lesbian, gay or bisexual adults who are caring for a person with dementia 2024
Roybal Translational Research Center to Promote Context-Specific Caregiving of Community-Dwelling Persons Living with Alzheimer's Disease or Related Disorders: (Pilot) TBD Hepburn. Ken (Pilot PI: Prizer, Lindsay), Emory University, UT Health San Antonio Couple in Control (CiC) is a toolkit of communication skills and decisional strategies to help couples experience MCI cope with various challenges. dyads of partners, one of which is diagnosed with MCI 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 N Gitlin, Drexel University WeCareAdvisor, an online tool to help caregivers manage behavioral 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 ADRD Caregivers of persons living with AD/ADRD 2025
Impact of Adult Day Services on Psychosocial and Physiological Measures of Stress among African American Dementia Family Caregivers TBD Lauren Parker, Johns Hopkins University Mechanism study to identify how adult day services influences caregiving related stressors and needs for African American AD/ADRD caregivers 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 AD/ADRD Rural, African American, and white care partners for those living with AD/ADRD 2026
Testing Dementia Caregiver TeleCoaching to Reduce Episodes of Abuse and Neglect by Recognizing and Managing Care-Resistant Behaviors TBD Rita A Jablonski, University of Alabama at Birmingham M 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 ADRD 2026
Family-Based Interventions
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers Yeonsu Song, UCLA Manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy AD patient-caregiver dyads (Ages 60+) 2022
A non-pharmacological intervention for patients with Alzheimer s disease and family caregivers A Non-pharmacological Intervention for Patients with Alzheimer's Disease and Family Caregivers (Care Partners Program) (CPProgram) Sara J Czaja, Weill Medical College of Cornell University Dyadic cognitive/functional training intervention delivered through a computer tablet to improve quality of life, distress, and caregiving efficacy, among other outcomes Dyads of individuals with mild AD and their CGs (Ages 21+) 2022
Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons with Dementia Care to Plan: A Tailored Resource for Family Members of Persons With Dementia Joseph E Gaugler, University of Minnesota Care to Plan, a tailored resource that provides overview of types of AD/ADRD caregiver interventions, administers risk assessment, and creates individualized service recommendations and resources to ADRD caregivers Family caregivers (Ages 30-70) 2022
Daily Engagement in Meaningful Activities Professional (DEMA-Pro) intervention for seniors with subjective cognitive decline and living at home TBD Yueh-Feng Yvonne Lu,  Indiana University-Purdue University at Indianapolis Telephone intervention to teach patient-caregiver dyads problem solving, self-management and communication skills, and enhance interactions Individuals with subjective cognitive decline living at home and their caregivers  2022
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers Yeonsu Song, UCLA Manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy AD patient-caregiver dyads (Ages 60+) 2023
Creating a Faith-Based Toolbox for African Americans Living with Moderate and Severe Dementia Faith-Based Toolbox for African Americans With Dementia Fayron Recha Epps, Emory University Faith-based home activity toolkit (Faith-HAT), meaningful religious and spiritual activities for PLWD to engage in at home with their family caregiver Dyads of persons living with dementia and caregiver (Ages 18+) 2023
Reducing Disability via a Family-centered Intervention for Acutely-ill Persons with Alzheimer's Disease and Related Dementias A Family-centered Intervention for Acutely-ill Persons With Dementia Marie Boltz, Pennsylvania State University - University Park Family-centered Function-focused Care (Fam-FFC), an educational empowerment model for family caregivers that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD Older persons with Alzheimer's disease and related dementias (ADRD) and their family CGs 2023
Old SCHOOL Hip Hop: A randomized controlled trial to improve dementia knowledge Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge James Mccallum Noble, Columbia University Health Sciences “Old SCHOOL Hip Hop” (Seniors Can Have Optimal aging and Ongoing Longevity [OSHH]), a brief multimedia culturally tailored school-based intervention designed to teach minority children (4th and 5th grade; ages 9-11y) key dementia signs and symptoms, and actions taken when dementia is recognized Students at twenty schools (Ages 9-11; with their parents Ages 20+) 2023
STAR Caregivers - Virtual Training and Follow-up STAR Caregivers - Virtual Training and Follow-up (STAR-C-VTF) Robert B Penfold, Kaiser Foundation Research Institute STAR Virtual Training and Follow-up (STAR- VTF) - PWD caregiver training using web-based Electronic Health Record portal. Caregiver-PWD dyads (Ages ≥55) 2023
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 A 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) 2023
Improving Caregiver Health and Well-Being
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
The Residential Care Transition Module The Residential Care Transition Module (RCTM) Joseph E. Gaugler, University of Minnesota Residential Care Transition Module (RCTM), six formal sessions of consultation to family caregivers who have recently admitted a relative to a Residential Long-term Care setting Family caregivers (Ages 21+) who have recently admitted a relative to residential long-term care program 2022
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP) Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients Joshua Chodosh, New York University School of Medicine The Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP), an intervention involving typical dementia care management procedures provided by nurse care managers and care manager assistants to reduce recurrent ED visits and improve caregiver symptoms of depression, anxiety and need for social support ADRD care-recipients (Ages 75+) who present to the emergency department and are to be discharged home, and their family caregivers (Ages 21+). 2022
Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention (CGMI-V) Olimpia Paun, Rush University Medical Center Chronic Grief Management, a live streaming video to improve general well-being and satisfaction with care ADRD caregivers (Ages 60+) 2022
Mindfulness Meditation and Insomnia in Alzheimer's Disease Caregivers: Inflammatory and Biological Aging Mechanisms Mindfulness Meditation and Insomnia in Alzheimer's Disease Caregivers (CARES) Michael R Irwin, UCLA Mindful Awareness Practices for Insomnia (MAP-I) - a mindfulness meditation treatment for insomnia that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan. Spousal caregivers with insomnia (Ages 45-95) 2022
Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers Susan Gaylord, University of North Carolina, Chapel Hill Telephone-delivered mindfulness training designed to alleviate caregiver burden Rurally-located African American caregivers 2022
Translating a Dementia Caregiver Intervention into a Mobile Application Translating a Dementia Caregiver Intervention Into a Mobile Application Geoffrey N Tremont, Rhode Island Hospital Mobile health app to deliver mind-body intervention to family caregivers Dementia caregivers (Ages 18+) 2022
SAGE LEAF: Reducing Burden in Alzheimer’s Disease Caregivers through Positive Emotion Regulation and Virtual Support TBD Dershung Yang, Brightoutcome, Inc SAGE LEAF, a positive emotion regulation intervention tailored to a self-guided online version Adult caregivers (Ages 18-90) 2022
Mindfulness based stress reduction for family caregivers of dementia patients Improving Well-Being for Older Adult Family Dementia Caregivers Kathi L Heffner, University of Rochester Mindfulness Based Stress Reduction (MBSR) 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 R Fowler, Indiana University - Purdue University at Indianapolis An early screening intervention involving sending letters to dyads and the primary care PCP informing them of the results of the screening, for earlier diagnosis Dyads of older adults (Ages 65+) and family members (Ages 21+) 2023
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 T Moskowitz, Northwestern University of Chicago LEAF, Life Enhancing Activities technology-based intervention to reduce burden and increase well-being for family caregivers of persons living with AD/ADRD Caregivers (Ages 34-87) 2023
Mobile, Web-based Behavioral Intervention for Improving Caregiver Well-being Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being Brent T 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) 2023
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 Lynn 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+) 2023
CuidaTXT: a Text Message Dementia-Caregiver Intervention for Latinos CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos (CuidaTXT) Jaime Perales, University of Kansas Medical Center CuidaTXT [Spanish for self-care and texting), a culturally and linguistically tailored text message intervention for caregiver support of Latinos with dementia Latino Caregivers of individuals with ADRD (Ages 18+) 2023
Mindfulness-based Cognitive Coping Mobile App Intervention for caregivers of individuals with Alzheimer's Disease TBD 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 ADRD 2023
Developing a Culturally-sensitive Volunteering Program to Reduce Stress of Dementia Caregivers in Chinese American Communities Volunteering Program for Chinese Dementia Caregivers Jinyu Liu, Columbia Univ New York Morningside Peer Mentoring Program (PMP) for Chinese caregivers of persons living with dementia Caregivers (Ages 21+) 2024
Midwest Roybal Center for Health Promotion and Translation: OCEAN: Optimizing Cognition via Exercise and Nutrition (pilot) TBD Hughes, Susan (Pilot PI: Aguinaga, Susan), University of Illinois at Chicago BAILAMOS™ is a Latin dance program and MIND (Mediterranean-DASH) is a diet - the program with dance and diet aims to improve cognitive function Older Latinos (ages 50+) 2024
Midwest Roybal Center for Health Promotion and Translation: HealthMatters@24/7 eLearning for People Supporting Adults With Intellectual and Developmental Disabilities (pilot) HealthMatters@24/7 eLearning for People Supporting Adults With Intellectual and Developmental Disabilities (HM@24/7) Hughes, Susan (Pilot PI: Marks, Beth), University of Illinois at Chicago HealthMatters@24/7 is an on-demand e-Learning platform for staff training to improve staff job performance for staff caring for adults with intellectual and developmental disabilities Staff caring for adults with intellectual and developmental disabilities 2024
Midwest Roybal Center for Health Promotion and Translation: VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment (supplement) VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment Hughes, Susan (Pilot PI: Bhatt, Tanvi), University of Illinois at Chicago VR-CogMoBal) is a virtual reality based cognitive-motor balance training Community-dwelling older adults with mild cognitive impairment 2024
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 Hughes, Susan (Pilot PI: (Mirza, Mansha), University of Illinois at Chicago IPROACTIF is an occupational therapist-delivered primary care intervention for aging and chronic disease management Community-dwelling men and women, ≥ 55 years of age 2024
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 Hughes, Susan (Pilot PI: Hsieh, Kueifang (Kelly)), 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
Midwest Roybal Center for Health Promotion and Translation: CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults (pilot) CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults Hughes, Susan (Pilot PI: Bhatt, Tanvi), University of Illinois at Chicago CogXergaming is a cognitive-motor exercise -gaming using Nintendo Wi-fit for frail older adults to improve balance, muscle fitness, cardiovascular fitness and global cognition Frail older adults aged 60 and up 2024
Rochester Roybal Center for Social Ties and Aging Research: Social-Life Enhancing Activities for Caregivers(Pilot) Social-Life Enhancing Activities for Caregivers Kathi Heffner, 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: Engage Coaching for Latinos (Pilot) Engage Coaching for Latinos Kathi Heffner, Caroline Silva, University of Rochester intervention to identify culturally-specific barriers of social connectedness for Spanish speaking caregivers of persons with AD/ADRD Hispanic/Latino caregiver for a community-dwelling family member with AD/ADRD 2024
Rochester Roybal Center for Social Ties and Aging Research: Mindfulness to Reduce Loneliness in Older Caregivers (Pilot) Mindfulness to Reduce Loneliness in Older Caregivers Kathi Heffner, Autumn Gallegos, University of Rochester Mindfulness training for the reduction of social isolation and feelings of loneliness in older caregivers of family members with ADRD Caregiver for a community-dwelling family member with AD/ADRD (Ages 50+) 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 Kathi Heffner, University of Rochester Life Review therapy, a behavioral intervention to address social connection in caregivers by focusing on the caregiving relationship Caregivers (Ages 50+) and care receiver with MCI and advanced cancer 2024
Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals with Alzheimers Disease and Other Dementias Caregiver Speaks: A Technologically Mediated Storytelling Intervention Debra Parker Oliver, Washington University 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 (PLWD; ages 18-120) 2024
Using Twitter to Enhance the Social Support of Hispanic and Black Dementia Caregivers (Tweet-SS) Twitter Based Social Support for Hispanic and Black Dementia Caregivers (Tweet-S2) Sunmoo Yoon, Columbia University Health Sciences Twitter-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: Pilot 1.2. A Multidomain Intervention for Older People with Vascular Dementia (Pilot) Multidomain Intervention Programs for Older People with Dementia Walter Ladson Hinton, University of California at 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 TBD Walter Ladson Hinton, University of California at 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 Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam Walter Ladson Hinton, University of California at 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 a Dementia Family Caregiver Support Intervention in Vietnam Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease Walter Ladson Hinton, University of California at Davis Paper - based cognitive training Vietnamese patients with early Alzheimer's disease and their caregivers 2024
Evaluating the feasibility of a mobile phone-based intervention on depression, anxiety, and stress of the dementia caregiver Evaluating the Feasibility of a Mobile Phone-based Intervention on Depression, Anxiety, and Stress of the Dementia Patients' Caregivers Walter Ladson Hinton,  University of California at 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 for Caregivers (CRx-C) Stacy Tessler Lindau,  University of Chicago Community Rx-Caregiver Resources - tailored resources addressing health-related social needs (HRSN) for caregivers.  ADRD caregivers (Ages 18+) 2024
Fostering Caregiver Connections via Intentional Technology Pairing for Caregivers of Patients with Alzheimer's Disease and Other Types of Dementia TBD Kevin M Kramer, Minnesota Health Solutions 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 TBD Sheria Grice Robinson-Lane,  University of Michigan at Ann Arbor Culturally tailored support intervention for African American caregivers of PLWD to reduce health disparities African American caregivers of a PLWD (Ages 55+) 2025
Mobile app delivered Mentalizing Imagery Therapy to augment remote family dementia caregiver skills training: a pilot randomized, controlled trial with outcomes assessment using digital phenotyping Mobile App Psychological Interventions for Family Dementia Caregivers Felipe A Jain,  Massachusetts General Hospital Guided imagery and mindfulness therapy delivered via mobile app to augment dementia caregiver skills training Primary caregiver who is aged 60+ for a relative with 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 PLWD 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 Missouri-Columbia 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 & PWDs 2026
Supporting Family Caregivers of Persons with Dementia TBD 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 ADRD 2026
Improving Surrogate Communication and Decision Making
Project Name Trial Name on CT.gov 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 R Fowler,  Indiana University-Purdue University at 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 AD (Ages 75+) and a family caregiver (Ages undefined) 2023
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 C Dickerson,  Massachusetts General Hospital Video-based decision aids (user manuals) to improve decision making skills for caregivers of persons with early-onset dementia Caregivers of those with young-onset patients with ADRD (Patient ages ≤65; caregiver ages undefined)  2023
A communication-based intervention for early stage dementia patient-caregiver dyads to increase engagement in advance care planning and reduce caregiver burden ADRD Patient-Caregiver Intervention for Advance Care Planning Sara Czaja, Weill Medical College of Cornell University Communication-based intervention to improve preparedness for advance care planning (ACP) ADRD patient and caregivers 2023
Shared Decision-Making for Firearm Safety among Older Adults with early changes associated with Alzheimer’s Disease/Alzheimer’s Disease-Related Dementias (AD/ADRD) TBD Laura C Prater, University of Washington Shared Decision Making (SDM) video decision aid to improve safe firearm storage and decision quality among persons with MCI/early dementia and/or depression who own firearms Persons with MCI/early dementia and/or depression who own firearms 2023
Safety in Dementia: An Online Caregiver Intervention. TBD Marian Elizabeth Betz, University of Colorado Denver 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
Negotiation Training to Optimize Caregiver Communication in Alzheimer's Disease Negotiation Training for Caregiver Communication in AD Lee A Lindquist,  Northwestern University at Chicago Negotiation and dispute resolution training program for caregivers with PLWD Adult family caregivers of PLWD that provide at least 10 hours weekly support 2025
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 Leslie Brown,  Florida International University Assistive alternative communication device for PLWD 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 Bonds Johnson, Emory University Tailored strategies to support formal care decision-making processes African-American parent-adult daughter dyad 2026
Interventions in Formal Care Settings
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Mentoring and Research in Patient-Oriented Geriatric Emergency Care Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D) Manish Shah, University of Wisconsin-Madison Adaptation of a community paramedic coaching program for caregivers of persons with dementia Older adults with mild to moderate dementia (Ages 60+) and their caregivers 2022
A Nursing Home Pragmatic Clinical Trial of APPROACHES (Aligning Patient Preferences: a Role Offering Alzheimer's patient, Caregivers, and Healthcare providers Education and Support) Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Education and Support Susan E. Hickman, Indiana University School of Nursing Advance Care Planning (ACP) Specialist Program (Aligning Patient Preferences: a Role Offering Alzheimer's patients, Caregivers, and Healthcare providers Education and Support (APPROACHES)) to improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by existing NH staff ADRD patients and their family caregivers, and nursing home providers 2022
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study George Netscher, SafelyYou, INC. SafelyYou system based on AI-enabled cameras which detect fall related events to prevent emergency room visits and help with care of individual  Residents of care facilities (particularly facilities with high populations of individuals with AD/ADRD) at high fall risk 2022
Enhancing Sleep Quality for Nursing Home Residents with Dementia:  Pragmatic Trial of an Evidence-Based Frontline Huddling Program Enhancing Sleep Quality for Nursing Home Residents With Dementia (40Winks) A Lynn Snow, University of Alabama in Tuscaloosa Nursing home frontline staff huddling program to improve clinical outcomes for individuals with AD/ADRD Individuals with Alzheimer's disease or related dementia 2022
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living Jeanne A Teresi (Contact); Mark Steven Lachs; Karl A Pillemer, Hebrew Home for the Aged at Riverdale Resident-to-resident elder mistreatment (R-REM) training for front-line long-term care staff to aid in recognition, management and reporting of R-REM Front-line long-term care staff  2023
Feasibility of the VOICES Elder Mistreatment Digital-Screening Tool for Older Adults with Cognitive Impairment Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility) (VOICES-PC) Fuad Abujarad, Yale University VOICES elder mistreatment digital screening tool for older adults with cognitive Impairment Older adults with cognitive Impairment 2023
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, Boston 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 ADRD, as well as proxy decision-makers (Ages 65+) 2023
Optimal Medication Management in Alzheimer's Disease and Dementia Optimal Medication Management in Alzheimer's Disease and Dementia (Optimize) Elizabeth Bayliss, Kaiser Foundation Research Institute  Pragmatic deprescribing intervention to improve medication management and improve overall health Older adults with AD/ADRD or Mild Cognitive Impairment (MCI) 2023
Enhanced Quality in Primary Care for Elders with Diabetes and Dementia (EQUIPED-ADRD) Enhanced Quality in Primary Care for Elders with Diabetes and Dementia (EQUIPED-ADRD) Joshua Chodosh, New York University School of Medicine Care quality improvement intervention Individuals with AD and AD/ADRD 2023
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)_part2 (METRIcAL) 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 2023
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 Aizer 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 PWD and support to their informal caregivers through hospice Hospice agencies 2023
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+) 2023
NIA AD/ADRD Health Care Systems Research Collaboratory: Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department (Pilot) Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department (IMPACT) Ula Hwang, Yale School of Medicine intervention based in emergency departments for cognitive impairment screening and outpatient assessment referral  Community-dwelling individuals discharged from the ED (65+) 2023
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 ADRD Nursing Home residents living with ADRD and interventionalists (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: Pragmatic Trial (Trial 1) (PICSI-H) J Randall Curtis,  University of Washington EHR-based Clinician Jumpstart intervention to promote goals-of-care communication for older patients with serious illness. Older Adults (Ages 80+, or 65+ with 1+ chronic condition) 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) J Randall Curtis,  University of Washington EHR-based Clinician Jumpstart intervention to promote goals-of-care communication for older patients with serious illness. Older Adults (Ages 80+, or 65+ with 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 ADRD admitted to the hospital (Ages 55+) 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: ALIGN: Aligning Medications with What Matters Most (Pilot) Aligning Medications With What Matters Most (ALIGN) Ariel Green, Johns Hopkins University A pharmacist-led deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners Dyads of persons living with dementia and their caregiver 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Can Value Champions Reduce Inappropriate Prescribing for People with Dementia? (Demonstration Project) TBD 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) TBD Michael Lepore,  LiveWell Alliance 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) (Demonstration Project) TBD Vincent Mor, Richard Platt, Xiaojuan Li,  Brown University, Harvard Pilgrim Health Care Institute  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) TBD 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 ADRD 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Effect of a COVID-specific advance care planning intervention on documentation of advance directives and goals of care (Supplement) Effect of an Advance Care Planning Intervention Vincent Mor, Ellen McCreedy, Brown University COVID-specific advanced care planning intervention for documentation of care preferences in assisted living community (ALC) residents with AD/ADRD  People living with AD/ADRD and their family members 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 PLWD 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,  Baylor College of Medicine 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: Tele-ACP Intervention in those with Unrecognized Dementia or Cognitive Impairment (Pilot) A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (ACP) Jennifer Gabbard, Wake Forest School of Medicine Telehealth advanced care planning (ACP) intervention for patients with either the diagnosis of mild cognitive impairment (MCI) or unrecognized dementia Patient-caregiver dyads for patients with a diagnosis of MCI or high risk of unrecognized 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) Mor, Vincent (Pilot PI: Totten, Annette), Brown University ADVANCE-PC is Aligning Dementia & adVANce Care planning Education in Primary Care settings and ECHO is remote technology used to deliver the advanced care planning education clinicians/staff, PLWD 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Virtual Training for Latino Caregivers to Manage Symptoms of Dementia (Pilot) TBD Mor, Vincent (Pilot PI: Ramirez, Magaly), Brown University STAR-VTF  is a program that teaches caregivers skills to reduce behavioral and psychological symptoms of dementia caregivers of PLWD 2024
NIA AD/ADRD Health Care Systems Research Collaboratory: Implementation of MIND at Home Program in Primary Care for Patients Living with Dementia (Pilot) TBD Mor, Vincent (Pilot PI: Ciemins, Elizabeth), Brown University 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) TBD Mor, Vincent (Pilot PI: Hanson, Leah R.), Brown University 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
NIA AD/ADRD Health Care Systems Research Collaboratory: COVID-19 SEROLOGIC STRATEGIES FOR SKILLED NURSING FACILITIES (CERO) (Supplement) COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO) Joshua Chodosh, Vincent Mor, NYU Langone Health, Brown University Intervention that leverages the COVID-antibody and PCR status of residents and staff to inform staff-residents care assignments to minimize COVID-19 transmission rates People living with AD/ADRD and those who are living in congregant environments such as Skilled Nursing Facilities (SNF) and staff members of SNFs 2024
Improving Post-Diagnosis Dementia Care in Primary Care TBD Halima Amjad, Johns Hopkins University 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, UT 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 Health Sciences Cognitive screening program for incident MCI or ADRD Older adults with critical illness 2026
Changing Talk Online Training (CHATO): A National Trial to Reduce Behavioral Symptoms in Long Term Care Residents with Alzheimer's Disease and Other Dementias (Supplement) 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
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
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 (PLWD) and their primary care partners 2027
Prototype Multimedia ADRD Falls Prevention System for Family Caregivers TBD Victoria Panzer, Brookside Research & Development Company FallScape for Dementia (FS-D), an innovative caregiver-provided daily treatment utilizing proprietary multimedia and behavioral intervention methods to reduce falls for people living with dementia Dyads of Caregiver and Person living with Dementia 2023
Interventions in Home or Informal Care Settings
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Older Adults Living with Alzheimer's Disease and their Caregivers: Testing an Evidence-Based Intervention for Underserved Populations Innovations in Dementia Empowerment and Action (IDEA) Karen Ilene Fredriksen-Goldsen ; Linda Teri,  University of Washington   Standard and Enhanced versions of Reducing Disabilities in Alzheimer's Disease (RDAD) designed to increase exercise engagement and promote effective problem solving among caregivers (CGs) and their care recipients (CRs) with ADRD Dyads of care recipients with AD/ADRD and their caregivers (Ages 50+) 2022
Assessing a Novel Virtual Environment that Primes Individuals Living with AD/ADRD to Accomplish Activities of Daily Living. TBD Mandy Salomon, Mentia Dtx, Inc. DevaWorld, a technology-based intervention to assess whether consistent performance of Activities of Daily Living (ADL) inside DevaWorld by PLWD reduces caregiver stress Dyads of adults with ADRD and their caregivers 2022
A Technology-Based Novel Functional Skills Assessment and Training Program for Adults with and without Cognitive Impairments. Develop the next generation software solution A Novel Computer-Based Functional Skills Assessment and Training Program Peter Kallestrup,  I-Function, INC. Technology-based integrated functional-skills assessment and tailored training program (CFSAT) to enhance functional skills, help prevent or treat functional declines, and foster the functional independence and well being of older adults People with Mild Cognitive Impairment (Ages ≥ 60) 2022
K23 Study 3: A Feasibility Study of CAPABLE Transitions for Older Adults with ADRD CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition Adam C. Simning, University of Rochester CAPABLE Transitions, an occupational therapy-led multidisciplinary in-home intervention to help older adults transition to their homes following hospital or post-acute care facility discharge. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention. Adults recently discharged from a hospital or post-acute care facility and admitted to a Medicare-certified home health agency (CHHA) with and without dementia (Ages 65+) 2023
Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design TBD Natalie Regier,  Johns Hopkins University Service user-led meaningful activity intervention to treat mild dementia People that are mild or early stages of dementia (Ages ≥60) 2023
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+) 2023
A Multi-Site Cluster RCT of the Dementia Symptom Management At Home Program The Dementia Symptom Management at Home Program (DSM-H) Abraham Aizer Brody,  New York University Home healthcare improvement intervention to manage dementia patients in the home setting People with dementia (Ages ≥65) 2023
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 University Activity-based home healthcare to treat people with dementia People with dementia (Ages 55+) and caregivers (Ages 18+) 2023
A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults TBD Judith Tate, Ohio State University Post Intensive Care Unit Problem Solving (PIC-UPS), an in-home strategy training intervention designed to overcome cognitive problems Older adult ICU survivors who have cognitive impairment 2023
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 AD's level of function 2023
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. TBD Kyle Patrick Rand, Rendever, Inc. Rendever virtual reality (VR) platform designed to improve quality of life of residents with AD/ADRD in senior living communities and their adult children who live at a distance Dyads of residents with AD/ADRD in senior living communities and their adult children 2023
Care4AD: A Comprehensive Care Coordination and Management Platform for Alzheimer's Disease and Related Dementias  Care Coordination System for People With Dementia Ashkan Vaziri; Bijan Najafi,  Biosensics, Llc Care4AD, a comprehensive care platform to improve care for AD patients Adults with mild to moderate AD (Ages ≥ 56) 2023
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 (Ages 55-90) with diagnosis of dementia, cognitive impairment, or memory loss 2024
Decision Making Among Older Adults: the AUTO study Advancing Understanding of Transportation Options (AUTO) Marian Elizabeth Betz,  University of Colorado Denver 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 Taylor Ptomey,  University of Kansas, Lawrence Moderate physical activity intervention for adults with Alzheimer’s Disease and their Caregivers to improve mobility Adults with mild moderate AD 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 Worcester Patient/caregiver-centered, multifaceted educational intervention on inappropriate prescribing  Older adults with AD/ADRD 2025
Using design thinking approaches to tailor a dyadic behavioral sleep intervention for persons living with dementia and their caregivers TBD Glenna Shemida Brewster, 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 (PLwCI) and their caregivers 2026
Music-based Intervention for Insomnia in Persons Living with Dementia and their Caregivers TBD Darina V Petrovsky, RBHS-School of Nursing Tailored music-based mobile application aimed at improving insomnia symptoms in PLWD Underrepresented community-dwelling PLWD and their caregivers 2026
Long-Term Care Services and Supports and Care Coordination
Project Name Trial Name on CT.gov 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 N Gitlin,  Johns Hopkins University 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 30 ADS sites (Ages 21+) 2022
Home-delivered meals for persons with dementia: Which model delays nursing home placement? Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement? Kali St Marie Thomas,  Brown University Home food delivery comparison (frozen food bulk drop off by postal carrier vs daily drop off by meal provider) to delay nursing home placement Persons living with dementia, mild cognitive impairment, or memory loss that are on waitlist for home-delivered meals (Ages 66+) 2022
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 Laurel Possin,  UCSF 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
Other
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Accessible Hearing Care for Reduction of Disruptive Behaviors and Caregiver Burden in Dementia TBD Carrie L Nieman,  Johns Hopkins University 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 AD/ADRD  Older adults with dementia and their caregivers (Ages 18+) 2023
Novel Approaches to Identifying and Engaging Disadvantaged Patients with Alzheimer's Disease (AD) in Clinical Research TBD Andrea L Gilmore-Bykovskyi,  University of Wisconsin-Madison Intervention to test a tailored clinical trial registry to inform best practices for acute care research recruitment as well as engagement/retention of research participants  Patient/caregiver dyads (Patient Ages 65+) 2023
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 2023
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 University PLAN, a dementia literacy training using to train community health workers Community health workers and dyads, i.e., patients with probable dementia (Ages 65+)/caregiver (Ages 18+) 2024
Behavioral Change Following Culturally-Informed Biomarker Disclosure in Alzheimer’s Disease TBD Annalise Rahman-Filipiak, University of Michigan at Ann Arbor 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 MCI 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 University Develop and implement a practical primary care based intervention to facilitate collaboration across care management programs Older adults with AD/ADRD 2026
Communication in the Hospital: Impact on Patients with Alzheimer's Disease and Other Causes of Cognitive Impairments and their Surrogate Decision Makers.  TBD Alexia M Torke, Indiana University-Purdue University at Indianapolis Randomized pilot of video visits to connect the surrogate decision makers of incapacitated, hospitalized older adults with AD and related causes of cognitive impairment with the patient and clinicians Surrogate decision makers of incapacitated, hospitalized older adults with AD and related causes of cognitive impairment and the older adult patient 2026
Massachusetts AI and Technology Center for Connected Care in Aging and Alzheimer's Disease (MAITC) TBD Deepak Ganesan, University of Massachusetts Amherst TBD TBD 2025
Palliative and End-of-Life Care
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Palliative Care at Home for Patients with Dementia Palliative Care at Home for Dementia Nathan E Goldstein,  Icahn School of Medicine at Mount Sinai Home-based palliative care for older adults with dementia and caregivers Persons with advanced dementia and their caregivers 2022
Indiana Palliative Excellence in Alzheimer Care Efforts-RCT Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) Greg Sachs,  Indiana University-Purdue University at 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) 2023
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 Scott Halpern, University of Pennsylvania intervention to test an 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 LTSS 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 Scott Halpern, University of Pennsylvania a machine-learning mortality prediction model to identify nursing residents with late-stage AD/ADRD appropriate for  hospice informational referrals to reduce goal-discordant hospital transfers nursing home residents with late-stage AD/ADRD 2024
Transforming residential palliative care for persons with dementia through behavioral economics and data science: Understanding And Improving Uptake Of Tele-Palliative Care For Persons With Dementia In Long-Term Care Facilities During COVID-19 (Pilot) TBD Scott Halpern, University of Pennsylvania intervention to identify barriers and facilitators of tele-palliative care (T-PC) for Persons With Dementia (PWD) in long-term services and support (LTSS) facilities stakeholders and family members of PWD 2024
Enhanced Dementia Instruction and Tool in Home Hospice Care (EDITH-HC) TBD Elizabeth Luth,  Weill Medical Coll of Cornell University 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 provide home hospice to PLWD; 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 Ethan Cox,  Duke University PCplanner-augmented care and PCplanner mobile, to will allow patients/family members to report their needs in a platform viewable by ICU physicians 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 N=200 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 C Hanson,  University of North Carolina, Chapel Hill Dementia-specific palliative care intervention involving caregiver education and transitional care Dyads of hospitalized patients with late stage 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 T Unroe,  Indiana University-Purdue University at Indianapolis Palliative care intervention utilizing palliative care champions to consult and help surrogate decision makers  Surrogate decision makers for PLWD in nursing homes 2025
Staff Training and Professional Development
Project Name Trial Name on CT.gov 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, Chapel Hill RCT to test a program to provide daily mouth care to reduce bacteria in the mouth that lead to aspiration pneumonia for assisted living residents Residents with dementia, care staff, and dental hygienists (Ages 18+)  2023
Nursing Home Prevention of Injury in Dementia (NH PRIDE) Nursing Home Prevention of Injury in Dementia (NH PRIDE) Sarah Berry, Hebrew Rehabilitation Center for Aged 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  2023
SPEEKO for Elderspeak: A Self-Monitoring App to Improve Communication and Do: Reduce Behavioral Symptoms in Care for Persons with Alzheimer's Disease and Other Dementias Speeko for Elderspeak Kristine N Williams,  University of Kansas Medical Center CHAT Training Program to educate staff about elderspeak and communication strategies with nursing home residents Dyads (Ages 18+) 2023
Technology Assisted Monitoring and Care
Project Name Trial Name on CT.gov 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 MCI who live in a Spanish language home (Study 2). Caregivers must have an iPhone or Android phone.   2023
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 MCI who live in a rural home (Study 1). Caregivers must have an iPhone or Android phone.   2023
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 MCI in homes with Apple Watch. Caregivers must have an iPhone or Android phone.   2023
A smartphone application to improve physical activity in underactive older adults Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia Stacey Niemiec, University of Southern California Physical activity (PA)-tracking smartphone app and specialty features to improve functional and overall health outcomes Older adults (Ages 65-84) 2022
Developing a widely-useable wearable Circadian Profiling System to assess 24-hour behavioral rhythm disruption in people with dementia and their family caregivers TBD Stephen Smagula, Activity Rhythm Solutions Corp Circadian Activity Profiling System (CAPS), a new "digiceutical" platform designed to provide real-time monitoring to address sleep disruptions Individuals living with ADRD and their care partners (dyads) 2022
Remote Patient Monitoring of Family Caregivers of Patients with Alzheimer's Disease TBD Jonathan Nicolla, Prepped Health, LLC "Digital Outpost," a remote patient monitoring platform designed Caregivers and patients with ADRD 2022
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 Jenay Beer, Applied Universal Dynamics Corporation Socially-assistive robot to deliver cognitive training in the form of a music (piano) learning intervention Older adults (Ages 65+) 2022
Interactive Companion Robot for Preventing Neuro-Cognitive Decline in Alzheimer's and Other Dementias TBD Chris Berka, Advanced Brain Monitoring, Inc. Mabu Robot, a socially-assistive robot that will be used in an adaptive and interactive platform to motivate, encourage, and reward participants for increasing physical activity Healthy adults (a subset of Advanced Brain Monitoring (ABM) INSPECDS study population in San Diego County; ages 55-75). 2022
Autonomous Navigating Telepresence Robot for Alleviating Loneliness and Engaging Nursing Home Residents with and without Dementia TBD Yuval Malinsky, Vigorous Mind, Inc. Autonomous navigating telepresence robot with proven web-based scheduling and communications (Zoom) systems and a proven activities platform, to address loneliness and isolation Residents of nursing homes with AD/ADRD 2022
Social Assistive Robot Interface for People with Alzheimer's and Other Dementias to Aid in Care Management TBD Daniel S. Hedin, Advanced Medical Electronics Corporation Socially-Assistive Robot (SAR) to engage PWD in a detailed natural language conversation as psychosocial support PWD and their caregivers who live (or work) in an Assisted Living Facility.  2022
Extending Independence And Quality Of Life For People With Alzheimer's Disease Or Dementia Through Telehealth Program Delivery Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers Cynthia Louise Benjamin, Together Senior Health, Inc. Moving Together, a livestream virtual group program delivery to improve quality of life for persons with dementia Dyads of persons with mild ADRD or MCI and their primary caregivers 2022
Development of Serious Games and Physical Activities Instructed by a Social Robot for Improving the Well-being of Elderly Individuals with Alzheimer’s Disease and Dementia Socially Assistive Robots for Interaction With Older Adults With Dementia Mohammad Mahoor,  Dream Face Technologies, LLC Socially assistive robot for electronic gameplay that targets cognition, memory, spatial relation, social relationship, and motor skills Persons diagnosed with mild AD/ADRD (Ages 65+) 2022
Development and Usability Evaluation of a Mobile Health Intervention to Support Healthful Dietary Choices in Older Persons with Dementia TBD Oleg Zaslavsky, University of Washington  Mobile-based Health Intervention to improve adherence to the Mediterranean Diet Adults, with mild to moderate frailty, and own or have access to a cellphone (Ages 65+) 2023
Feasibility of the SmartPrompt for Improving Everyday Function in Dementia Feasibility of the SmartPrompt for Improving Everyday Function in Dementia (SmartPrompt) Tania Giovannetti,  Temple University SmartPrompt, an electronic reminder aid for persons living with dementia to target specific cognitive difficulties and help with everyday tasks Diverse sample of older adults with mild dementia and their caregivers (Ages 65-90) 2023
The BRAIN App: Building Relationships using Artificial Intelligence and Nostalgia TBD Skrajner, Michael John, The Hearthstone Institute LLC BRAIN app delivering cognitive stimulation therapy to PWD People living with dementia 2023
LEAD IT! An App to Enable Persons with Early Stage Dementia to Lead Group Activities for Their Peers LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers Michael John Skrajner,  Hearthstone Alzheimer's Care LTD LEAD IT!, an app-based intervention to encourage persons with early stage dementia to lead group activities with their peers in nursing home or assisted living facilities Persons living with early stage dementia in nursing homes or assisted living facilities (Ages 65+) 2023
Enhancing Quality of Life for Older Adults With and Without MCI through Social Engagement Over Video Technology TBD Dillon Myers, Potluck LLC OneClick 3.0, social engagement over video technology platform for those with and without MCI to evaluate its efficacy in affecting social engagement and quality of life Participants with and without mild cognitive impairment (Ages 65-85) 2023
A Mobile Informatics Solution to Aid in Memory A Mobile Informatics Solution to Aid in Memory Gary D Havey, Advanced Medical Electronics Corporation 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+) 2023
Using gamification, predictive analytics, artificial intelligence, and Alexa Voice to optimize user experience for individuals living with AD/ADRD and their caregivers TBD 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 AD/ADRD 2023
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 Jeffrey Kaye (Pilot PI: Sarah T. Stahl), Oregon Health & Science University  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) Jeffrey Kaye, Oregon Health & 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 AD/ADRD 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: READyR: Remote Assessment and Dynamic Response Intervention to Support Couples in Planning for Changing Dementia Care Needs (Pilot) REmote Assessment and Dynamic Response Intervention II (READyR-II) Jeffrey Kaye, Oregon Health & Science University Intervention to test a dynamically tailored needs assessment for care planning for PWD and their care partner Care partners and persons living with dementia 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: SHARE-sense: A Dyadic Care Planning Intervention Program for Early-Stage Dementia Integrating In-Home Objective Sensing of Behavioral Patterns (Pilot) REmote Assessment and Dynamic Response Intervention (READyR) Jeffrey Kaye, Lyndsey Miller, Oregon Health & Science University READyR (also known as SHARE-sense; Support, Health, Activities, Resources, and Education Program) for dementia care planning in care partners and PLWD dyads Care partners and persons living with dementia 2024
ORCASTRAIT Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology: Tele-STELLA: Using Technology to Advance ADRD Family Education and Support (Pilot) Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology (STELLA) Jeffrey Kaye, Allison Lindauer, Oregon Health & Science University STELLA (Support via Technology Living and Learning with Advancing Alzheimer's disease and related dementias), a multicomponent video-conference based intervention to reduce upsetting behaviors and care partner burden Caregivers who live together with a person living with mid-to-late stage AD/ADRD 2024
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
Improving Alzheimer's Disease and Related Dementias Care in Rural Areas TBD Patricia Prusaczyk, Washington University  A communication and care coordination tool for providers of patients with AD/ADRD. The exact health information technology (HIT) tool to be tested is unknown and will be identified during Aim 2 of this proposal.  Providers of care for AD/ADRD 2026

Section 5: Other Types of Trials

Diagnostic Tools, Assessment, & Imaging Studies
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
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 Αβ burden and assess lymphatic drainage function Older adults with Parkinson's Disease (Ages 55-80) 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 (UCSD) Identify sensitivity levels of memantine, an NMDA receptor antagonist approved for treatment of moderate-to-severe AD Older adults with AD 2023
Actigraphic assessment of sleep quality in the A4 trial TBD Paul Rosenberg, Johns Hopkins University Noninvasive measure of sleep (actigraphy) Cognitively healthy individuals with evidence of amyloid in brain (Ages 65-85) 2022
A Cognitive Risk Calculator and Screening tool for Primary Care Settings TBD Darlene Floden, Cleveland Clinic Lerner College of Medicine-CWRU 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+) 2022
A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment TBD Leah R Hanson,  HealthPartners Institute EHR cognitive impairment clinical decision support tool to improve early detection and management of cognitive impairment Patients with elevated dementia risk 2022
Cognitive Screening Made Easy for Primary Care Providers TBD Robin C Hilsabeck, University of Texas at Austin Cognitive screening tool for primary care providers to conduct cognitive screenings on a regular basis Adults who are cognitively normal, mild cognitive impairment, or have dementia (Ages 60+) 2022
Enriching clinical trials requiring amyloid positivity with practice effects Enriching clinical trials requiring amyloid positivity with practice effects Kevin Duff, University of Utah Explore relationship between short-term practice effects on cognitive tests and amyloid PET scan Cognitively intact older adults, and those with MCI and AD (Ages 65+) 2023
Slow wave sleep (SWS) and the effect of African ancestry on amyloid burden, a longitudinal study The Sleep Amyloid, Slow WAve Race and Ethnicity Study (Sleep AWARE) Ricardo Osorio, New York University School of Medicine Explore whether poor slow wave sleep is a predictor of amyloid burden Cognitively normal African-American and White adults (Ages 55-75) 2023
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 AD stages Cognitively normal older adults (Ages 60-75) 2023
Holistic Evaluation to Advance Research in Dementia (HEARD): Phased Interdisciplinary Infrastructure Development and Pilot Studies TBD Sheila Molony, Quinnipiac University Development, standardization and validation of new outcome measures and methods for psychosocial interventions Older adults with AD 2023
Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care TBD Maria Orlando Edelen, RAND Corporation EHR dementia screening tool, implemented in clinical practice to increase early detection of cognitive impairment Providers of patients (Ages 65+) 2023
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 2023
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 Sascha Dublin, Kaiser Foundation Research Institute 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 TBD Brianne Magouirk Bettcher, University of Colorado Denver Home-based video Tele-neuropsychological assessment (TeleNP) versus a face-to-face (FF) neuropsychological assessment in older adults with suspected AD/ADRD for the delivery of neuropsychological evaluations. Care recipient ≥age 60 years and <90 years who are undergoing evaluation for possible AD and whose severity ranges from MCI to mild dementia. care partner: (no inclusion criteria provided) 2024
Low-cost detection of dementia using electronic health records data: validation and testing of the eRADAR algorithm in a pragmatic, patient-centered trial TBD Sascha Dublin, Kaiser Foundation Research Institute EHR dementia screening tool to detect cognitive impairment Older adults enrolled in Kaiser Washington or UCSF care within the past 2 years with no prior diagnosis of dementia (Ages 65+) 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 Richard Gershon, Northwestern University at Chicago Cognitive assessment toolbox to detect cognitive decline in Medicare Annual Wellness visits Older Adults/Patients (Ages 65+) 2025
Digital Detection of Dementia Studies (D cubed Studies) Digital Detection of Dementia (D Cubed) Studies (Dcubed) Malaz Boustani, Indiana University- Purdue University at Indianapolis A machine learning and patient-reported outcome tool for early detection of cognitive impairment Older adults receiving health services (Ages 65+) 2025
Evaluating cognitive impairment as a moderator of locomotor learning in older adults post-stroke TBD 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
Treating Neuropsychiatric Symptoms of AD/ADRD (non-pharm)
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Problem Adaption Therapy for Mild Cognitive Impairment with Depression Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI) Dimitris Kiosses; Paul Rosenberg, Weill Medical College of Cornell University; Johns Hopkins 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+) 2022
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 Jeffrey 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 2022
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 Peter Forester; Georgios Petrides,  McLean Hospital;  Zucker Hillside Hospital Electroconvulsive Therapy to treat severe agitation in moderate to severe stage AD 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 improve sleep Individuals with AD and sleep problems (Ages 65+) 2025
Treating Neuropsychiatric Symptoms of AD/ADRD (pharm)
Project Name Trial Name on CT.gov Principal Investigator/Institution Trial Description Population Anticipated Completion Date
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD Jessica B Kendrick, University Of Colorado Denver Sodium bicarbonate therapy treatment to improve cognitive function Midlife and older men and women from all racial/ethnic backgrounds with chronic kidney disease (CKD) stage 3b-4 (Ages 50-75) 2022
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 AD People with Alzheimer's disease and agitation (Ages 60-90) 2023
Escitalopram for Agitation in Alzheimer's Disease Escitalopram for Agitation in Alzheimer's Disease (S-CitAD) Constantine Lyketsos; Anton Porsteinsson, Johns Hopkins University; University of Rochester Escitalopram, a small molecule selective serotonin reuptake inhibitor (SSRIs) antidepressant to treat agitation in AD People with Alzheimer's disease and agitation (Open to all adults meeting inclusion criteria) 2023
Lifes end Benefits of CannaBidol and TetrahYdrocannabinol (LiBBY) Trial TBD Jacobo Mintzer; Brigid Reynolds,  Medical University of South Carolina Cannabidol and Tetrahydrocannabinol, Cannabis chemotypes, to improve quality of life in adults with AD Adults with AD  2023
Nighttime Agitation and Restless Legs Syndrome in People with Alzheimer's Disease Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease Kathy Richards, University of Texas, Austin Gabapentin Enacarbil, an antiepileptic drug to reduce nighttime agitation, reduce restless legs syndrome behaviors, and improve sleep Older adults with dementia diagnosis and with nighttime agitation (Ages 55+) 2023