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

Page last updated: February 10, 2021

The National Institute on Aging (NIA) is currently supporting 270 active clinical trials on Alzheimer’s disease and related dementias (AD/ADRD). These prevention and intervention trials are diverse with respect to the drug and mechanistic targets as well as the stages of AD/ADRD that are addressed. NIA’s active trials include: early-stage clinical drug development, late-stage clinical drug development, non-pharmacological interventions, clinical therapy development for neuropsychiatric symptoms of dementia, and care and caregiver interventions. Please see the lists below for more details about these trials.

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

Amyloid Beta
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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 Susan Catalano, Cognition Therapeutics Inc CT1812 (sigma2 receptor antagonist) Mild to Moderate Alzheimer's Disease Ages 50-85) 2021
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 (glutaminyl cyclase (QC) inhibitor) (treats both amyloidopathy and neuroinflammation) Adults with MCI or mild probable AD (Ages 50-89) 2023
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 20mg citalopram QD or placebo over 2 years in patients in PD without depression  65 years and older adults with PD diagnosis and no active depression 2025
COG0202, A Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimers Disease over 18 Months TBD Susan Catalano, Cognition Therapeutics Inc CT1812 (sigma2 receptor antagonist) Older adults with early AD (late mild cognitive impairment - mild AD dementia) 2025
Multiple Ascending Dose clinical trial of PTI-125, a novel AD therapeutic candidate and Open-label extension of a 3-month blinded clinical trial of PTI-125 Open-label, PK and Safety Study in Mild-to-moderate Alzheimer's Disease Patients Lindsay H. Burns, Pain Therapeutics Inc PTI-125 (filamin A (FLNA), a protein critical to beta amyloid's toxicity) Mild to Moderate Alzheimer's Disease (Ages 50-85) 2022
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 Non-demented adults with down syndrome (Ages 35-55) 2021
A Pilot Synaptic Vesicle Glycoprotein 2A (SV2A) PET Study to Evaluate the Effect of CT1812 Treatment on Synaptic Density in Subjects with Mild to Moderate Alzheimer's Disease Effect of CT1812 Treatment on Brain Synaptic Density Susan Catalano, Cognition Therapeutics Inc CT1812 (sigma2 receptor antagonist) People with Alzheimer's disease (Ages 50-85) 2022
A Pilot CSF Catheter Study to Evaluate the Effect of CT1812 Treatment on Aβ Oligomer Clearance into CSF in Subjects with Mild to Moderate Alzheimer's Disease Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease Susan Catalano, Cognition Therapeutics Inc CT1812 (sigma2 receptor antagonist) People with Alzheimer's disease Ages 50-80) 2021
A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimerʼs Disease TBD Susan Catalano, Cognition Therapeutics Inc CT1812 (sigma2 receptor antagonist) Mild to moderate AD patients (Ages 50-80) 2021
Discover Study (CSF Sampling: Safety, Tolerability, PK and PD of Posiphen)* Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease (DISCOVER) Douglas Galasko, University of California, San Diego Posiphen (inhibitor of amyloid precursor protein (APP) processing) People with amnestic Mild Cognitive Impairment or mild Alzheimer's disease (Ages 55-85) 2022
Growth Factors and Hormones
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
A double-blinded, randomized, controlled phase 2a safety, proof-of-concept and exploratory end point trial of the drug LM11A-31 in patients with mild to moderate Alzheimer's disease Study of LM11A-31-BHS in Mild-moderate AD Patients Manfred Windisch, PharmatropiX-NeuroScios Inc LM11A-31 (p75 neurotrophin receptor (p75NTR)) (function to increase survival signaling and inhibit amyloid-β-induced degenerative signaling) People with Alzheimer's disease (Ages 50-85) 2021
The LUCINDA Trial The LUCINDA Trial: LUpron Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA) Tracy Butler (Contact), New York University School of Medicine; James Galvin, Florida Atlantic University; Craig Atwood, University of Wisconsin Lupron (gonadotropin-releasing hormone (GnRH) receptor agonist) Women with mild-moderate Alzheimer's Disease who are also taking AChEl (Ages 65-90) 2022
 
Inflammation
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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, Cleveland Clinic; Boris Decourt, Arizona State University Lenalidomide (Anti-inflammatory immunomodulator) Adults with amnestic Mild Cognitive Impairment (Ages ≥50) 2024
First-in-human SAD & MAD trials for MW151, a novel Alzheimer's disease drug candidate that attenuates proinflammatory cytokine dysregulation MW151-101: First-in-human Study of MW151 Linda Van Eldik, Northwestern University Feinberg School of Medicine MW151 (selectively suppress proinflammatory cytokines)) Healthy volunteers (Open to all adults meeting inclusion criteria) 2021
Development of a stress kinase inhibitor therapeutic candidate for Alzheimers Disease and related dementia TBD Wayne Anderson, Neurokine Therapeutics, LLC MW150 (a p38alphaMAPK serine/threonine protein kinase Mild to Moderate Alzheimer's Disease (Ages 50-85) 2024
 
Metabolism and Bioenergetics
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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  (PPARγ and PPARδ agonist) Adults with mild to severe AD (Ages 50-90) 2023
Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive Impairment and Mild Alzheimers 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 Mild cognitive impairment (MCI) and mild Alzheimer’s disease (mild-AD) subjects (aged 55-89 years old) 2025
 
Multi-target
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Evaluation of Brain and Cognitive Changes in Older Adults with MCI Taking Lithium to Prevent Alzheimer Type Dementia Lithium As a Treatment to Prevent Impairment of Cognition in Elders (LATTICE) Ariel Gildengers, University of Pittsburgh Medical Center Lithium (GSK3α and GSK3β  inhibitor) People with Mild Cognitive Impairment Age (Ages ≥60) 2022
Safety and Pharmacokinetics of JOTROL for Alzheimers Disease TBD Marshall Hayward , Jupiter Orphan Therapeutics, Inc. JOTROL, A high bioavailability orally administered form of Resveratrol (stabilizer of Aβ40 and Aβ42 accumulation) Normal healthy volunteers ages 18 - 75 2021
 
Neurogenesis
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Neuron regenerative therapeutic, NNI-362, for first-in-human safety and PK for AD Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers Judith Kelleher-Andersson, Neuronascent Inc NNI – 362 (modulates the phosphorylation of p70S6K) (drug functions as neuron regenerative therapy) Healthy volunteers (Ages 50-72) 2022
A randomized, placebo-controlled, double-blind study to evaluate safety and efficacy of NDX-1017 treatment in Alzheimers dementia patients TBD Xue Hua, Athira Pharma, Inc NDX-1017, an  hepatocyte growth factor (HGF) system agonist 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 Intervention 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 (precursor to Nicotinamide adenine dinucleotide (NAD+)) People with amnestic Mild Cognitive Impairment  (Ages 60-90) 2022
Mid-Career Program for Vascular Contributions to Alzheimers disease Candesartan's Effects on Alzheimer's Disease And Related Biomarkers (CEDAR) Ihab Hajjar, Emory University Candesartan (agiotensin receptor blocker) Age 50 years and older 2025
Sleep Quality and Human Amlyoid-Beta Kinetics Sleep Quality and Amyloid-Beta Kinetics Brendan Lucey, Washington University Sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights 45-65 year old adults 2021
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 (Vitamin D receptor) 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 Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS) Oluwaseun Johnson-Akeju, Massachusetts General Hospital Preemptive biomimetic sleep induction in reducing the incidence of delirium >=60 yrs old scheduled for cardiac surgical procedure 2021
Anti-viral therapy in Alzheimer's disease Anti-viral Therapy in Alzheimer's Disease Davangere Devanand, Columbia University Valacyclovir (Anti-HSV drug) People with mild Alzheimer's disease (Open to all adults meeting inclusion criteria) 2022
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 Subjects in the intensive treatment arm will receive calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs to reduce 24-hour SBP ≤ 120 mmHg. Compared to standard care arm targeted to reduce 24-hour SBP ≤ 130mmHg. 55 Years to 79 Years older adults with hypertension 2022
The Use of Deferiprone to Improve Subarachnoid Hemorrhage Cognitive Outcome: U-DISCO TBD David M Hasan, University of Iowa Deferiprone to improve cognitive outcomes Adults ages 18 - 70 with aneurysmal subarachnoid hemorrhage at risk for cognitive decline 2025
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 Hydrochloride Older adults >65 years with abdominal adiposity and impaired fasting glucose 2021
 
Oxidative Stress
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
2-Hydroxybenzylamine for the prevention of Alzheimer’s disease: Initial Evaluation in Humans 2-HOBA: Multiple Dosing Study in Older Adults (2-HOBA) John Rathmacher, Metabolic Technologies Inc 2-hydroxybenzylamine  (γ-ketoaldehyde scavenger) Healthy volunteers (Ages 60-79) 2021
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  (antioxidant) Adults with MCI (Ages 65-80) 2022
Glutathione, Brain Metabolism and Inflammation in Alzheimers Disease TBD 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 (aged 55-85 years old) 2025
 
Receptors
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
The delivery of essential fatty acids to the Brain in Alzheimer's disease DHA Brain Delivery Trial (PreventE4) Hussein Yassine, University of Southern California Docosahexaenoic acid (DHA) (lipid) Healthy adult carriers and non-carriers of APOE ε4 (Ages 60-80) 2022
Long Term Nicotine Treatment of Mild Cognitive Impairment Memory Improvement Through Nicotine Dosing (MIND) Study (MIND) Paul Newhouse, Vanderbilt University; Paul Aisen, Alzheimer's Therapeutic Research Institute Nicotine (Nicotinic receptor agonist) People with Mild Cognitive Impairment (Ages ≥55) 2026
 
Sleep
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 (regulates sleep cycle) Older adults (Ages 60-75) 2024
 
Synaptic Plasticity/Neuroprotection
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Treating hyperexcitability in Alzheimer’s disease with levetiracetam to improve brain function and cognition Treating Hyperexcitability in AD With Levetiracetam Mouhsin Shafi, Harvard Levetiracetam (synaptic vesicle protein (SV2A) modulator) 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 (inhibits CSF tyrosine kinase Abelson (facilitates autophagic degradation of neurotoxic proteins and promotes survival of neurons) Adults with clinical diagnosis of DLB with both dementia and Parkinsonism (Ages 25-90) 2023
(-)-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 (Inhibits neuronal pre-programmed cell death) Adults with probable AD (Ages 70-82) 2024
Allopregnanolone as Regenerative Therapeutic for Alzheimer's: Phase 2 Clinical Trial TBD Roberta Diaz Brinton, University of Arizona; Kathleen E. Rodgers, University of Arizona; Lon S. Schneider, University of Southern California Allopregnanolone (stimulates anti-inflammatory mechanisms and mitochondrial function) Adults who are APOEe4 positive and diagnosed with mild AD (Ages ≥ 55) 2025
Network-Level Mechanisms for Preclinical Alzheimer’s Disease Development Network-Level Mechanisms for Preclinical Alzheimer's Disease Development Shi-Jiang Li, Medical College of Wisconsin Healthy adults, carriers of APOE ε4 (Ages 55-75) Healthy adults, carriers of APOE ε4 (Ages 55-75) 2021
Long-term therapeutic effects of synthetic bryostatin-1 in advanced AD without memantine TBD Miao-Kun Sun, Neurotrope Bioscience Inc Bryostatin-1 (activates PKCε in the hippocampus) Adults with advanced AD (Ages 55-85) 2022
 
Vasculature
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 (angiotensin II receptor blocker) Non-hypertensive adults with Mild Cognitive Impairment (Ages ≥40) 2021
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 and Peter Nelson, University of Kentucky Nicorandil (agonist for sulfonyl urea receptor 2 protein (SUR2)) Adults with probable Hippocampal sclerosis (HS)-aging (Ages ≥ 75) 2024

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

Amyloid Beta
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
DIAN-TU 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-Amyloid Cognitively healthy or mildly impaired adults who are Alzheimer's disease genetic mutation carriers (Open to all adults meeting inclusion criteria) 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; Paul Aisen, Alzheimer's Therapeutic Research Institute; Keith Johnson, Massachusetts General Hospital BAN2401 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
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, Banner Health; Pierre Tariot, Banner Health; Francisco Lopera, Universidad De Antioquia Crenezumab  (anti-amyloidβ antibody) Cognitively healthy adults who are Alzheimer's disease genetic mutation carriers  (Ages 30 to 60) 2023
Combination anti amyloid therapy for preclinical Alzheimers 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 Reisa Sperling, Brigham And Women's Hospital; Paul Aisen, Alzheimer's Therapeutic Research Institute; Keith Johnson, Massachusetts General Hospital BAN2401 Cognitively healthy older adults with "elevated" amyloid levels on screening PET. (Ages 55–80. Adults 55 – 64 must have an additional risk factor) 2024
A4 Trial  Anti-Amyloid treatment in Asymptomatic Alzheimer's Disease Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss (A4) Reisa Sperling, Brigham and Women's Hospital Solanezumab  (anti-amyloidβ antibody) Cognitively healthy older adults who are amyloid positive on brain imaging (Ages ≥65) 2024
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study TBD Susan Abushakra, Alzheon, Inc. ALZ-801 (tramiprosate pro-drug), an inhibitor of Aβ oligomer formation APOE4/4 Early AD patients 2025
DIAN-TU Primary 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) Eric Martin Mcdade, Washington University Anti-amyloid therapy TBD Individuals at risk of dominantly inherited Alzheimer's disease (Open to all adults meeting inclusion criteria) 2025
* = The DIAN-TU Tau Next Generation Prevention Trial has two grants – R01AG068319 (anti-amyloid) is the first arm and R01AG068319 (anti-tau) is the second arm  
Synaptic Plasticity
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 antagonist) Adults with amnestic Mild Cognitive Impairment (Ages 55-85) 2022
Phase II/III Trial for Slowing Progression in Mild Cognitive Impairment Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (Hope4MCI) Michela Gallagher and Marilyn Albert, Johns Hopkins University Levetiracetam (LEV) (synaptic vesicle protein (SV2A) modulator) People with Mild Cognitive Impairment (Ages 55-85) 2022
Tau
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 Cognitively healthy or mildly impaired adults who are Alzheimer's disease genetic mutation carriers (Open to all adults meeting inclusion criteria) 2025
* = The DIAN-TU Tau Next Generation Prevention Trial has two grants – R01AG068319 (anti-amyloid) is the first arm and R01AG068319 (anti-tau) is the second arm  
Vasculature
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in older Adults (PREVENTABLE) Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE) Karen Alexander, Duke University Atorvastatin 40mg or placebo Adults 75 years or older without atherosclerotic CVD or dementia 2026

Section 3: Non-Pharmacological Interventions

Assistive Technology/Device
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 (counseling program combined with a low-cost, over-the-counter amplification device) 20 older adults with dementia and their caregivers (18+) 2023
Mobile Assessment of Behavioral and Psychological Symptoms of Dementia in Adults with Alzheimer’s Disease The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study (MOMENT) Daniel Bateman, Indiana University-Purdue University at Indianapolis  Smartphone-based ecological momentary assessment (EMA)  96 AD patient-caregiver dyads Age is 18+ (caregiver) 2024
Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Frank Lin and Josef Coresh, Johns Hopkins University Hearing aid placement 70 to 84 years 2022
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 plus education N=137 residents from 12 senior AL facilities; Ages 62+ 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. 55 years and older adults with mild to moderate Alzheimer's Disease diagnosis and Type 2 diabetes 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 (smartphone technology) Diverse sample of older adults with mild dementia (N = 40) and their caregivers (N =40) Ages 65-90 2021
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment Novel Arm Restraint in the Intensive Care Unit Renee Needham Stapleton and Dale Murray, Healthy Design Ltd. Co. Novel Arm Restraints Adults 65 or older who are critically ill 2021
Accurate WiFi-Based Localization of Dementia Patients for Caregiver Support Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support Suneel Ismail Sheikh, ASTER Labs Inc Activlink 187 participants; 21-85 years old  Study 2a: dementia patients residing in skilled or memory care facilities  Study 2b: 80 independently dwelling mild dementia patients 2021
Enhancing Quality of Life for Older Adults With and Without MCI through Social Engagement Over Video Technology TBD Dillon Myers, Potluck LLC social engagement platform for those with and without MCI Participants Aged 65-85; subgroup with mild cognitive impairment 2022
Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment Gene Wang, People Power Company In-home technology 80 caregivers for PWDs (21+) 2022
Digital multidomain lifestyle intervention to address cognitive health and modifiable risk factors for Alzheimer's disease TBD Nicholas Bott, Neurotrack Technologies Inc Digital multi-domain AD risk reduction intervention 200 at-risk adults age 45-64 2023
A Mobile Informatics Solution to Aid in Memory TBD Gary D Havey, Advanced Medical Electronics Corporation Smartwatch reminder system Phase I = 20 dyads; Phase 2 = 100 dyads Caregivers aged 21+ 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 80 persons diagnosed with mild AD/ADRD 65+ 2021
 
Cognitive Training
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
The influence of multi-domain cognitive training on large scale structural and functional brain networks in MCI The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI Seyed Hosseini, Stanford University Computerized cognitive training People with Mild Cognitive Impairment (Ages 65-85) 2021
Working Memory Training in Older Adults TBD Susanne Madlaina Jaeggi, UC Irvine Aim 2: adaptive n-back task  Aim 3: adaptive n-back task + self-efficacy intervention Aim 2: 200 older adults Ages 65-85  Aim 3: 180 older adults Ages 65-85 2021
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 High polyphenol (MIND) foods combined with speed of processing cognitive training 180 older adults (60+) 2023
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 People with Mild Cognitive Impairment (Ages 55-95) 2022
Cognitive Regulation Training and Exercise (CORTEX)-II with Middle-aged Adults Cognitive Regulation Training and Exercise Trial (CORTEX-II) Sean P Mullen, University of Illinois at Urbana-Champaign CORTEX 250 participants (ages 35-64) 2021
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) 2022
Interventions to Attenuate Cognitive Decline Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp Jerri Edwards, University of South Florida Intense piano training 200 participants at least 60 years of age 2021
The Adherence Promotion with Person-centered Technology (APPT) Project: Promoting Adherence to Enhance the Early Detection and Treatment of Cognitive Decline TBD Walter Richard Boot, Florida State University APPT 2 RCTs – Study 1: N = 190, ages 65+, non-cognitively impaired) Study 2: Same as Study 1 Also includes small feasibility study: N = 20, ages 65+ 2024
Prospective memory impairment in Parkinson disease-related cognitive decline: Intervention and mechanisms Prospective Memory Impairment in PD-related Cognitive Decline (PMT2) Erin Foster, Washington University at Saint Louis Teaching participants memory encoding strategies to improve their prospective memory Males and females over age 50 who meet criteria for typical idiopathic PD 2025
Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease Comparing Smartphone Technology and a Memory Strategy on Improving Prospective Memory in Alzheimer's Disease Michael Scullin, Baylor University Smartphone People with mild Alzheimer's disease (No age restriction) 2021
Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's  TBD Grigore C. Burdea, Bright Cloud International Corporation Home-based custom Virtual Reality system People with mild Alzheimer’s disease (Ages ≥ 65) 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 and Mouna Attarha, Posit Science Corporation 10-week computerized congitive training program 108 healthy older adults aged 65+  2021
Plasticity-based Adaptive Cognitive Remediation for Alzheimer's Disease Phase II Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging) Hyun Kyu Lee, Posit Science Corporation Computerized cognitive training Cognitively healthy older adults (Ages ≥65) 2021
Preventing Alzheimer's Disease with Cognitive Training: The PACT Trial Preventing Alzheimer's Disease with Cognitive Training (PACT) Jerri Edwards, University of South Florida Cognitive speed of processing training (SPT) N=7600; Ages 65+ 2021
Strategic Training to Optimize Neurocognitive Functions in Older Adults Strategic Training to Optimize Neurocognitive Functions in Older Adults (ViCTOR)  Chandramallika Basak, The University of Texas at Dallas Increasing attentional control demands 26 older adults (55-85) 2021
Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia The Active Mind Trial Jerri Edwards, University of South Florida Combinations of cognitive training exercises Participants N = 60  Ages 65-89 2021
Elucidating the Necessary Components and Mechanisms of Cognitive Training TBD Lesley A Ross, Pennsylvania State University, University Park Bottom-up driven process-based training (BUD); top-down driven training (TDD, strategy-based cognitive training) Phase 1: N=160 adults  Phase 2: N=30  Phase 3: N=20  Ages 45-90 2021
Training Foundational Skills To Enhance Cognition In Older Adults Training to Enhance Cognition in Older Adults Jeanne Townsend, University of California-San Diego Gaze-driven training games 60-80 year old adults 2021
 
Combination Therapy
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Insulin Resistance, Biomarkers of Brain Function, and Intermittent Caloric Restriction Calorie Restriction and Brain Function in Mild Cognitive Impairment (5-2CR) Auriel A. Willette, Iowa State University Caloric Restriction + Dietary Counseling Older adults with Mild Cognitive Impairment aged 70-85 w/BMI between 28 and 40 and < 350 lbs. 2021
Cognitive and Aerobic Resilience for the Brain Cognitive and Aerobic Resilience for the Brain (CARB) Frederick Unverzagt, Indiana University Aerobic exercise training  Cognitive training People with Mild Cognitive Impairment (Ages ≥65) 2021
Exercise and Intensive Vascular Risk Reduction in Preventing Dementia Risk Reduction for Alzheimer's Disease (rrAD) Rong Zhang, UT Southwestern Medical Center;  Ellen Binder, Washington University; Jeffrey Burns, University of Kansas Medical Center; Munro Cullum, UT Southwestern Medical Center; Jeffrey Keller, Pennington Biomedical Research Center; Diana Kerwin, Texas Health Presbyterian Hospital Dallas Aerobic exercise and Atorvastatin Cognitively healthy older adults (Age ≥65) 2021
Augmenting Cognitive Training in Older Adults - The ACT Grant Augmenting Cognitive Training in Older Adults (ACT) Adam Woods, University of Florida Neurostimulation (tDCS) and cognitive training Adults aged 65 to 89 with age-related cog. decline 2021
Decreasing Alzheimer's Disease and Related Dementias after Delirium-Exercise and Cognitive Training Improving the Recovery and Outcome Every Day After the ICU (IMPROVE) Babar Khan, Indiana University Physical Activity and Brain HQ training Adults 65 or older with history of delirium 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 and Cognitive Training People with Mild Cognitive Impairment (Ages 65-74) 2022
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 People with Mild Cognitive Impairment (Ages ≥60) 2023
Multidomain Alzheimer's Risk Reduction Study (MARRS) Pilot Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT) Kristine Yaffe, University of California San Francisco; Eric Larson, Group Health Research Institute Multi-domain Alzheimer's risk reduction Individuals with subjective cognitive complaints (Ages ≥70) 2021
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 People with early Mild Cognitive Impairment (Ages 55-80) 2025
Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults with Mild Cognitive Impairment mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Amnestic Mild Cognitive Impairment (mSIM) Sarah Mcewen, John Wayne Cancer Institute Aerobic exercise and memory skills training program Adults with amnestic MCI (Ages 65-80) 2021
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)  TBD Cay Anderson-Hanley, John P. Arciero, Paul J. Arciero, Mina Dunnam, David Arthur Merrill, Stella E. Panos, and Emilie Saulnier, IPACES, LLC Physical and Cognitive Exercise System (iPACES v3)  People with MCI or subjective cognitive complaints (Ages ≥ 50) 2022
 
Decision Supportive
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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 Mammography decision aid 426 dyads consisting of an older woman with AD and a family caregiver; ages 75+ 2022
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 120 patient-surrogate dyads; ages 18+ 2022
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) Older drivers (n=300) 70+ without severe cognitive  impairment 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 Plan Your Lifespan 300 older adults 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) and Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2) (PICSI-H) J Randall Curtis, University of Washington Jumpstart Trial 1 (pragmatic trial): N=2000; Trial 2 (comparative effectiveness trial): N=440 Ages 80+ and 65+ (with 1+ chronic condition) 2024
 
Development of Diagnostic Tools
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Identifying and supporting patients with undiagnosed dementia using the EHR Risk of Alzheimers and Dementia Assessment Rule (eRADAR): a pilot clinical trial TBD Sascha Dublin, Kaiser Foundation Research Institute Leveraging EHR dementia screening tool to follow up with high risk patients with potential undiagnosed dementia 12,000 Ages 65+ enrolled in Kaiser Washington within the past 2 years with no prior diagnosis of dementia 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 Evaluating performance of EHR dementia screening tool and follow up in a pragmatic trial 27,000 Patients ages 65+ enrolled in Kaiser Washington or UCSF care within the past 2 years with no prior diagnosis of dementia 2025
ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings TBD Richard Gershon, Northwestern University at Chicago RCT to implement and evaluate cognitive assessment toolbox to detect cognitive decline in Medicare Annual Wellness visits Patients 65+ 2025
Digital Detection of Dementia Studies (D cubed Studies) TBD Malaz Boustani, Indiana University- Purdue University at Indianapolis ADRD early detection using machine learning and patient reported outcome tool 4,000 adults aged 65 and older receiving health services (local sample over 15 practices) 2025
A Cognitive Risk Calculator and Screening tool for Primary Care Settings TBD Darlene Floden, Cleveland Clinic Studying uptake and use of 2 cognitive screen tools in primary care settings Providers caring for patients 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 patients with elevated dementia risk 2022
Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care TBD Maria Orlando Edelen, RAND Corporation Evaluation and implementation of EHR dementia screening tool into clinical practice Phase 1: UPMC Patients Aged 65+ who completed PROMIS Cognitive Short Form & neuropsychiatric evaluation Phase 2: Patients in catchment area 65+ who have  Medicare Annual Wellness visits 2022
Cognitive Screening Made Easy for Primary Care Providers TBD Robin C Hilsabeck, University of Texas at Austin Cognitive screneing tool for primary care providers R61: Ages 60+ who are cognitively normal, mild cognitive impairmet, or have dementia R33: primary care participants who are 60+ 2022
 
Diet/Supplements
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)[SM([1] COcoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind) Laura Baker, Wake Forest University Health Sciences, Brigham and Women's Health Daily use of cocoa flavanols with or without a multivitamin 65 years and older 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 Cognitively health older adults (Ages 65-84) 2022
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 People with amnestic Mild Cognitive Impairment (Ages 55-85) 2023
Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer Disease Risk Multicultural Healthy Diet to Reduce Cognitive Decline (MHD) Yasmin Mossavar-Rahmani, Albert Einstein College of Medicine Multicultural Healthy Diet 40 to 65 years 2022
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 Cocoapro flavanols 50-69 years 2023
Enhanced Mediterranean Diet For Alzheimer's Disease Prevention Nutrition Interventions for Cognitive Enhancement (NICE) Debra Sullivan, University of Kansas Medical Center Mediterranean diet & Omega 3 supplement 65 years and older 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 People with Alzheimer's Disease Ages 50-90) 2023
 
Exercise
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition Independent Walking for Brain Health Zvinka Zlatar, UC San Diego Walking Healthy adults ages 65-75 2021
Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects Effects of Aerobic Exercise for Treating Alzheimer's Disease (FIT-AD) Fang Yu, University of Minnesota Aerobic exercise training People with Alzheimer's disease (Ages ≥66) 2021
Genes, Exercise, Neurocognitive and Neurodegeneration: Community –Based Approach Genes, Exercise, Neurocognitive and Neurodegeneration: Community-Based Approach (GEMSII) Thomas Obisesan, Howard University Aerobic exercise training People with Mild Cognitive Impairment (Ages 55–85) 2021
Effects of Physical Activity on Brain Function and Network Connectivity in MCI Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study Judy Pa, University of California at San Francisco Aerobic exercise training People with Mild Cognitive Impairment (Ages 60–80) 2021
Rhythm and Timing Exercises for Cerebral Vascular Disease in American Indians TBD Steven Verney, University of New Mexico Interactive Metronome (IM) therapy American Indians (Ages 68 to 80) 2021
Investigating Gains in Neurocognition in an Intervention Trial of Exercise Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) Kirk Erickson, University of Pittsburgh; Jeffrey Burns, University of Kansas; Edward Mcauley, University of Illinois Urbana-Champaign; Arthur Kramer, Northeastern University Walking Sedentary adults 65 to 80 2021
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 (Contact) and Linda Teri, University of Washington Enhanced Reducing Disabilities in Alzheimer's Disease (RDAD) 225 dyads of care recipients with AD/RD and their caregivers, ages 50+ 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 Fitness training Sedentary adults ages 55 to 80 2022
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 training Physically inactive adults ages 60 to 80 2022
Mechanical integrity of memory systems in mild cognitive impairment Aging Brain Structure and Memory in Response to Exercise Curtis Johnson, University of Delaware 3-month exercise intervention 60 healthy participants (65+) and 60 participants with aMCI 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 Adults with a family history of Alzheimer's Disease (Ages 40-65) 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 People with aMCI (Ages ≥65) 2024
Rhythm Experience and Africana Culture Trial Rhythm Experience and Africana Culture Trial (REACT) Kirk Erickson, University of Pittsburgh African dance exercise intervention African Americans aged 60-80 2023
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 N = 100 adults with mild moderate AD and their caregivers (n=100) Ages 55+ 2024
Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Reducing African Americans' Alzheimer's Disease Risk Through Exercise (RAATE) Robert Newton and Owen Carmichael, Pennington Biomedical Research Center Aerobic exercise & strength training African Americans 65-85 years old 2023
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 Acute Exercise People with Alzheimer's Disease (Ages ≥60) 2025
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 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 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) – mind-body exercise to reduce cognitive decline N=120 (split control and intervention) Aged 50-80 2024
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 6 month, yoga vs aerobic exercise vs stretching toning intervention 168 55-79 year old adults with normal cognition 2025
Reducing African Americans Alzheimers Disease Risk Through Exercise-MCI Cohort (RAATE-MCI) TBD Robert Lee Newton, LSU Pennington Biomedical Research Center exercise intervention to reduce risk in African Americans with MCI African Americans aged 65-85 with MCI 2025
Effects of mindful Feldenkrais exercises & strength training on cognitive executive function in independent living older adults TBD Gerhild Ullmann, University of Memphis The Feldenkrais Method 108 older adults age 65-85 2021
The entorhinal cortex and aerobic exercise in aging The Entorhinal Cortex and Aerobic Exercise in Aging (ECE) Karin Schon, Boston University Aerobic exercise Sedentary adults aged 60-80 2021
Social Dancing Intervention for older adults at high risk of Alzheimer's disease and other dementias: A pilot study Movement Intervention for Memory Enhancement (MIME) Joe Verghese, Albert Einstein College of Medicine, Inc Social (ballroom) dancing and active control (walking) interventions N=32 adults  Ages 65+ 2021
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 (physical activity, cognitive activity, diet, sleep, social activity) N=150 African-Americans Aged 50-65 2021
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer’s in at-risk Older Adults Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults Tom Plocher, Moai Technologies, LLC VRCT exergame that seamlessly integrates real-world cognitive tasks into a virtual environment that is synchronized with cycling on a stationary cycle. Age 65 years and older 2021
EXERT (Exercise MCI Trial) Exercise in Adults With Mild Memory Problems (EXERT) Laura Baker, Wake Forest University; Carl Cotman, University of California at Irvine Aerobic exercise training People with Mild Cognitive Impairment (Ages 65-89) 2022
 
Light Therapy
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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 and Mariana Figueiro, Rensselaer Polytechnic Institute Light Intervention People with aMCI or mild AD (Ages ≥ 65) 2024
 
Neurostimulation
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
TMS in preclinical and prodromal AD: Modulation of brain networks and memory TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory Jessica Collins, Massachusetts General Hospital Repetitive Transcranial Magnetic Stimulation (rTMS) People with amnestic MCI (Ages 60-85) 2024
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) People with Mild Cognitive Impairment (Ages ≥55) 2023
Treating mild cognitive impairment with transcranial direct current stimulation Stimulation to Undermine Dementia (STUD) Benjamin Michael Hampstead, University of Michigan at Ann Arbor Transcranial direct current stimulation (tDCS) People with Mild Cognitive Impairment (Ages ≥65) 2023
Treating Primary Progressive Aphasia And Elucidating Neurodegeneration In The Language Network Using Transcranial Direct Current Stimulation Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS Roy Hamilton, University of Pennsylvania High-density transcranial direct current stimulation (HD-tDCS) paired with a modified version of constraint induced language therapy 66 patients aged 45-80 with either nonfluent/agrammatic PPA or logopenic variant PPA (33 each) 2024
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) Adults with mild to moderate AD (Ages ≥45) 2023
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) People with Amnestic Mild Cognitive Impairment (Ages 50-80) 2025
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 570 adults across 7 experiments. Younger adults 18-30, older adults 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, and Gene Alexander, University of Florida Near-infrared light stimulation (808-904 nm) Older adults between 65 and 89 with subjective cognitive complains and family history of AD 2024
Non-Invasive Home Neurostimulation for Mild to Moderate Alzheimer's Disease: Double-Blind, Sham Controlled Randomized Clinical Trial Transcranial Direct Current Stimulation (tDCS) in Mild to Moderate Alzheimer's Disease (AD) Patients Joe Verghese and Helena Knotkova, Albert Einstein College of Medicine Transcranial direct current neurostimulation (tDCS) People with AD  (Ages ≥ 60) 2025
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)  TBD Dan Vlad Iosifescu, New York University School of Medicine; Paolo Cassano, Harvard University; Ricardo Osorio, New York University School of Medicine Transcranial Photobiomodulation (t-PBM) 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 and Andrew Leuchter, University of Caliornia, Los Angeles Theta burst transcranial magnetic stimulation (TBS) 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) People with probable AD (Ages ≥ 50)  2025
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) People with amnestic MCI (Ages 60-89) 2021
Cholinergic functions and modulation of the cingulo-opercular alertness network in LBD  TBD Nicolaas Ida Bohnen and Benjamin Michael Hampstead, University of Michigan at Ann Arbor Transcranial direct current neurostimulation (tDCS) Adults with Lewey Body Dementia 2022
 
Other
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Novel Therapeutic Interventions for Patients with Alzheimer's Disease and Comorbid Dysphagia Interventions for Patients With Alzheimer's Disease and Dysphagia Nicole Rogus-Pulia, University of Wisconsin-Madison Lingual strengthening and Saliva substitute People with Alzheimer's disease (Open to all adults meeting inclusion criteria) 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 Taith-based home activity toolkit (Faith-HAT) 30 PWD and caregiver dyads (ages 18+) 2023
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 and Mary Sano, Icahn School of Medicine at Mount Sinai Hyperbaric oxygen therapy People with Mild Cognitive Impairment (Ages ≥65) 2022
Conversational engagement to delay onset Alzheimer's Disease: Phase II Internet-based Conversational Engagement Clinical Trial (I-CONECT) Hiroko Dodge, Oregon Health & Science University Conversation based social interaction Cognitively healthy older adults (Ages ≥75) 2021
INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE study The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression (INCREASE) Daniela Moga and Gregory Jicha, University of Kentucky Medication management Non-demented older adults (Ages ≥65) 2022
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 Stress Reduction 65-85 year old, RH healthy older adults 2022
The Aging Brain Under General Anesthesia: Neurophysiology, Neuroimaging Biomarkers of Aging and Alzheimers Disease, and Post-Operative Cognitive Outcomes Cognitive and Neurophysiological Outcomes Associated With EEG-Guided Administration of General Anesthesia Patrick Purdon, Emery Brown, and Bradford Dickerson, Massachusetts General Hospital EEG-guided anesthetic management ages 65 to 85, who are having general surgery procedures, including but not limited to abdominal surgery, urological surgery, breast surgery, or gynecological surgery 2022
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 social interaction People with Mild Cognitive Impairment (Ages ≥75) 2022
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 Univ-Purdue University at Indianapolis digital Brain Safe mobile app Adults who have taken at least 1 anticholinergic medication within the past 90 days  (Ages ≥65) 2024
Returning Research Results that Indicate Risk of Alzheimer Disease to Healthy Participants in Longitudinal Studies TBD Sarah Hartz and Jessica Mozersky, Washington University Returning Research All Knight ADRC cognitive normal people who have had imaging studies within 18 months, APOE genotyping and are scheduled for annual visits.  (Open to all adults meeting inclusion criteria) 2025
Enhancing gamma band response to improve working memory in individuals with mild cognitive impairment  TBD Fiza Singh, University of California, San Diego EEG-neurofeedback (EEG-NFB) 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) African-Americans with amnestic MCI and poorly controlled DM (Ages ≥65) 2025
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 Cognitively healthy and adults with MCI  (Ages ≥ 60) 2021
Sleep
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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 Behavioral sleep intervention program 40 AD patient-caregiver dyads, 60+ 2022
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) People with obstructive sleep apnea and amnestic Mild Cognitive Impairment  (Ages 55-75) 2021
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) 2023
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 and Laura D. Baker, Wake Forest University Health Sciences In-home objective sleep assessments Alzheimer vulnerable adults (Ages 60-79) 2024
A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk  TBD Daniel Gartenberg, Proactive Life, LLC Internet of Things (IoT) devices, such as the FitBit, Apple Watch, and Oura Ring Cognitively healthy older adults (Ages ≥65) 2022
The Impact of Sex Hormones on Sleep-Dependent Memory in Young and Midlife Men and Women TBD Fiona C Baker and Sara Carole Mednick, SRI International Closed-loop memory reactivation 76 46-54 year old women 2024

Section 4: Clinical Therapy Development for the Neuropsychiatric Symptoms of Dementia

Non-pharmacological
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention 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, Cornell University; Paul Rosenberg, Johns Hopkins University Psychosocial therapy People with Mild Cognitive Impairment and depression (Ages ≥60) 2021
A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimers Dementia (ECT-AD) Electroconvulsive Therapy (ECT) for Agitation in Alzheimer's Dementia (AD) Brent Peter Forester McLean Hopital;  Georgios Petrides, Zucker Hillside Hospital Electroconvulsive Therapy People with moderate to severe stage Alzheimer's Disease (Ages ≥55) 2023
 
Pharmacological
Project Name Trial Name on CT.gov >Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Apathy in Alzheimer's Disease Methylphenidate Trial II (ADMET II) Apathy in Dementia Methylphenidate Trial 2 (ADMET2) Jacobo Mintzer, Krista Lanctot, Nathan Herrmann, Paul Rosenberg, and Roberta Scherer, Medical University of South Carolina Methylphenidate  (CNS stimulant, norepinephrine–dopamine reuptake inhibitor (NDRI)) People with Alzheimer's disease and apathy (No age restriction) 2021
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, Johns Hopkins University; Brent Forester, McLean Hospital Dronabinol  (appetite stimulant, synthetic form of THC, partial agonist of CB1/2 endocannabinoid receptors) People with Alzheimer's disease and agitation (Ages 60-90) 2022
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 1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks. 55 years and older adults with dementia diagnosis and with nightimte agitation  2022
Escitalopram for Agitation in Alzheimer's Disease Escitalopram for Agitation in Alzheimer's Disease (S-CitAD) Constantine Lyketsos, Johns Hopkins University; Anton Porsteinsson, University of Rochester Escitalopram  (antidepressant, selective serotonin reuptake inhibitors (SSRIs)) People with Alzheimer's disease and agitation (Open to all adults meeting inclusion criteria) 2023
PEACE-AD (Prazosin for Agitation In Alzheimer's Disease)* Prazosin for Agitation in Alzheimer's Disease Elaine Peskind and Murray Raskind, University of Washington Prazosin  (alpha-1 (α1) adrenergic receptor inhibitor) People with Alzheimer's disease and severe agitation (No age restriction) 2022

Section 5: Care and Caregiver Interventions (including Dementia Care and Impact of Disease)

Identifying, Assessing, and Improving Care and Quality of Life for Persons with Dementia
>Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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 Africian American caregivers of PLWD African American caregivers of a PLWD, aged 55+ 2025
Advancing Palliative Care for Older Adults Affected by Neurodegenerative Disease: Parkinsons disease, Alzheimers disease and Related Dementias TBD Benzi M Kluger, University of Rochester palliative care training for clinicians as part of virtual house calls Persons with Parkinson's disease, Lewy body Dementia, or related disorer, aged 40+, with palliatve needs 2025
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 People that are mild or in the early stages of dementia  (Ages ≥60) 2023
Optimizing Mealtime (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents with Alzheimers Disease and Related Dementias (ADRD) TBD Wen Liu, Univeresity of Iowa person-centered mealtime care intervention for nursing home residents with ADRD Nursing Home residents, aged 55+, living with ADRD and interventionalists 2024
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 Tailored clinical trial registry recruitment 30 patient/caregiver dyads 65+ 2023
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 Nurses or social workers who provides home hospice to PLWD; family caregivers 2022
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 300 caregivers 21+ initially enrolling their relative in one of the 30 ADS sites 2021
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 People with dementia (Ages ≥65) 2022
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  POLST Facilitation (advanced care planning, or ACP, intervention) N=438 frail, older community dwelling adults Ages 65+ 2024
The Care Ecosystem: Navigating patients and caregivers through stages of dementia care Care Ecosystem: Navigating Patients and Families Through Stages of Care Katherine Laurel Possin, UCSF Care Ecosystem 1050 persons with dementia 45+ and caregiver dyads 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, and Karl A Pillemer, Cornell University Training of nursing, social work, administrative and  other staff on R-REM 6 assisted living residence (ALRs) facilities 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 People with moderate to severe stage 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 People with dementia (Care givers Age ≥18, Volunteers Ages ≥55) 2023
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 250 older adults ≥65 managed in an ICU and their family members 2024
Pragmatic Trial of the Effectiveness and Cost-Effectiveness of Dementia Care D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care (D-CARE) David Reuben, University of California, Los Angeles Health system-based and community-based dementia care 2150 dyads of persons with dementia and their primary caregivers (18+) 2024
Efficacy of the WeCareAdvisor:  An Online Tool to Help Caregivers Manage Behavioral and Psychological Symptoms in Persons with Dementia TBD Laura N Gitlin, Drexel University WeCareAdvisor 326 caregivers 21+ 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 344 older adults 65+ 2024
Palliative care needs and outcomes for dementia patients Supportive Care for Cognitively Impaired Patients and Families Vyjeyanthi S Periyakoil, Stanford University Usual care plus an early palliative care intervention (EPC) N=200 Stanford ADRC participants  Ages 60-100 2023
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 (dementia literacy training) 288 patient/caregiver dyads Patient: Ages 65+ Caregiver: Ages 18+ 2024
Impact of a Novel Socially Assistive Robotic Architecture on Engaging Older Adults with Mild Cognitive Impairment, Alzheimers Disease, and Related Dementia in Long Term Care Settings TBD Nilanjan Sarkar, Vanderbilt University socially assistive robot to interact with LTC setting residents with either dementia or MCI PLWD or MCI in assisted living or nursing home facilities aged 70+ 2025
CommunityRx-Dementia CommunityRx for Caregivers (CRx-C) Stacy Tessler Lindau, University of Chicago CommunityRx-Dementia (CRx-D) 344 caregivers 18+ 2024
Palliative Care for Persons with Late-stage Alzheimers and Related Dementias and their Caregivers: a Randomized Clinical Trial TBD Laura C Hanson, University of North Carolina, Chapel Hill dementia-specific palliative care with 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 Alzheimers Disease) intervention Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease (UPLIFT-AD) Kathleen T Unroe, Indiana University-Purdue University at Indianpolis palliative care intervention utilizing palliatiave care champions to consult and help surrogate decision makers  Surrogate decision makers for PLWD in nursing homes 2025
Lifes end Benefits of CannaBidol and TetrahYdrocannabinol (LiBBY) Trial  TBD Jacobo Mintzer and Brigid Reynolds, Medical University of South Carolina CannaBidol and TetrahYdrocannabinol  Adults with AD  2023
Changing Talk Online Training (CHATO): A National Trial to Reduce Behavioral Symptoms in Long Term Care Residents with Alzheimers Disease and Other Dementias TBD Kristine N Williams, University of Kansas Medical Center Elderspeak and communication training to reduce behavioral symptoms in long term care settings Nursing home staff 2025
Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting Annalise Marie Rahman-Filipiak, University of Michigan at Ann Arbor Dementia – Alzheimer's Type (DAT) risk feedback protocols 50 patient-informant dyads 65+ (n = 25 cognitively intact participants, n = 25 participants with  MCI, and their respective informants) 2022
Building a Bridge (betwen clinical and community care): Post-diagnosis support of persons with dementia and their family) Building a Bridge (BAB) Between Clinical and Community Care (BAB) Sato Ashida, University of Iowa Options Counselor-Health Education (OC-HE) 80 family members of someone recently diagnosed with ADRD 18+ 2021
Me & My Wishes: An efficacy trial of long-term care residents with Alzheimer's using videos to communicate care preferences with caregivers Me & My Wishes: An Efficacy Trial Using Videos Gail L Towsley, University of Utah Me & My Wishes (videos of nursing home residents talking about their preferences for care) 54 nursing home residents 65+ 2021
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 120 family caregivers Ages 30-70 2021
Translating a Dementia Caregiver Intervention into a Mobile Application  Translating a Dementia Caregiver Intervention Into a Mobile Application Geoffrey N Tremont, Rhode Island Hospital Aim 1: FITT-C and a mind-body (yoga, meditation) intervention Aim 2: CARE-Well App Aim 1: N=10 dementia caregivers Aim 2: N=40 dementia caregivers (feasibility) Ages 18+ 2021
A Scalable Model for Promoting Functioning and Well-Being among Older Adults with Mild Cognitive Impairment via Meaningful Social Interactions: Project SPEAK! TBD John D Piette, University of Michigan at Ann Arbor Engage older adults with MCI as volunteers to help English Language Learners via videoconference to improve well being and cognitive function Older adults aged 55+ reporting loneliness on a validated measure 2022
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 who are age 65 or older; Imformants have knowledge of person with AD's level of function 2022
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) Vincent Mor, Brown University MUSIC & MEMORY (M&M) Music Program 81 Nursing Home facilities 2022
Pragmatic Trial to Improve Communication for Primary Care Patients with ADRD TBD Jennifer L Wolff, Johns Hopkins University Sharing Choices Patients 65+ in 100 primary care clinics 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) Stepped Wedge Trial Abraham Aizer Brody, New York University Dementia Symptom Management at Home Program Hospice Edition 25 hospice agencies 2023
A Technology-Based Novel Functional Skills Assessment and Training Program for Adults with and without Cognitive Impairments. Develop the next generation software solution TBD Peter Kallestrup, I-Function, INC. Technology-based integrated functional-skills assessment and tailored training program (CFSAT) People with MCI  (Ages ≥ 60) 2022
Fall Detection and Prevention for Memory Care through Real-Time Artificial Intelligence Applied to Video Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video Glen Xiong, SafelyYou, Inc. SafelyYou Guardian (online fall detection and prevention system) 460 patients in 19 memory care facilities (18+) 2021
LEAD IT! An App to Enable Persons with Early Stage Dementia to Lead Group Activities for Their Peers TBD Michael John Skrajner, Hearthstone Alzheimer's Care LTD 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 aged 65+ 2022
Care4AD: A Comprehensive Care Coordination and Management Platform for Alzheimer Disease and Related Dementias  Care Coordination System for People With Dementia Ashkan Vaziri and Bijan Najafi, Biosensics, Llc Comprehensive care platform  (Care4AD)  Adults with mild to moderate AD (Ages ≥ 56) 2023
Development of a reminiscence therapy online platform with machine learning to increase engagement with people living with dementia and their care partners TBD Lisbeth Sanders, Lifebio Inc online platform that stores stories, videos, and photos and uses information to make personalized reminiscence therapy exercises  40 Adult staff in assisted living facility with 160 dementia care dyads in assisted living care setting aged 55+ 2022
Palliative Care at Home for Patients with Dementia TBD 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 2021
Changing Talk Online (CHATO): A Pragmatic Trial to Reduce Behavioral Symptoms in Dementia Care Changing Talk Online (CHATO) Study Kristine Williams, University of Kansas Medical Center Changing Talk Online (CHATO) 150 nursing home staff members (18+) 2021
Home-delivered meals for persons with dementia: Which model delays nursing home placement? TBD 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, MCI, or memory loss that are on waitlist for home-delivered meals, aged 66+ 2021
 
Identifying, Assessing, and Improving Quality of Life and Care provided by Family or Informal Caregivers
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
A Culturally-relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population Vietnamese Caregiver Intervention Study Oanh L Meyer, UC Davis Culturally-relevant, multicomponent intervention addressing dementia with a novel  piece addressing cultural and inter-personal support in families 24 caregiver and secondary caregiver dyads, 21+ 2021
Stress resilience and aging in Alzheimer's disease and dementia caregivers TBD Alexandra Dupont Crosswell, University of California, San Francisco Expressive writing 60 family caregivers of Alzheimer's disease and dementia patients 50+ 2023
Developing a Screening Protocol for Family Caregivers of Older Persons with and without Dementia Seen in Primary Care TBD Catherine Riffin, Weill Medical College of Cornell University Caregiver screening-referral protocol for primary care 45 patient-caregiver dyads (65+) 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) 30 caregivers 21+ 2024
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 TBD 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
The Residential Care Transition Module The Residential Care Transition Module (RCTM) Joseph E. Gaugler, University of Minnesota Residential Care Transition Module (RCTM) 240 family caregivers 21+ who have recently admitted a relative to residential long-term care program 2021
Cognitive training to protect immune systems of older caregivers Cognitive Training for Older Caregivers (CTC) Kathi L Heffner, University of Rochester Computerized cognitive training 180 older caregivers (60-80 years old) of a family member with Alzheimer's Disease (AD) or AD-related dementia (ADRD) 2021
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) 240 women and men 60+, who currently live with and are the primary caregivers for a community dwelling  dementia patient 2021
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, University of Miami Dyadic cognitive/functional training intervention 240 dyads of individuals with mild AD and their CGs 21+ 2021
Testing Tele-Savvy, an On-line Psychoeducation Program for Informal Alzheimer's Caregivers Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers Ken W Hepburn (Contact) and Patricia C Griffiths, Emory University Tele-Savvy 216 informal caregivers (family/friends) 18+ of persons living with Alzheimer's 2021
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 “Old SCHOOL Hip Hop” (Seniors Can Have Optimal aging and Ongoing Longevity, OSHH) Twenty schools (with 3000 total students), 9+ (ages 9-11 with their parents aged 20+) 2022
The Caregiver Outcomes of Alzheimer's Disease Screening (COADS) Trial Caregiver Outcomes of Alzheimer's Disease Screening (COADS) Nicole R Fowler, Indiana University Earlier identification of Alzheimer's disease through screening 1,800 dyads (older adults 65+ and family members 21+) 2023
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, Online Intervention N=93 ADRD caregivers  [currently enrolled 144]  Ages 60+ 2021
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers (CARES) Michael R Irwin, UCLA Mindful Awareness Practices for Insomnia (MAP-I) 150 AD spousal caregivers 60+ 2022
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals with Alzheimer Disease and Related Dementias Rural Dementia Caregiver Project Veronica Yank, University of California, San Francisco Building Better Caregivers 640 rural dementia caregivers 18+ 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 for Family caregivers (3-arm technology-based RCT) N=500 caregivers  Ages 34-87 2023
Involving Family to Improve Advance Care Planning for Primary Care Patients with ADRD TBD Jennier L Wolff, Johns Hopkins University SHARE (communication intervention) 248 dyads (4 diverse primary care practices) SHARE (n=124 dyads) Usual care (n=124 dyads) Aged 80+ 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, University of Missouri-Columbia Caregiver Speaks 468  adult hospice family caregivers of person's living with dementia (PLWD; ages 18-120) 2024
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) N=100 caregiver-PWD dyads  Ages ≥55 2022
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 Behavioral Activation (BA) - mobile intervention N=200 dementia caregivers  Ages 40+ 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) online training and monitoring clinicians N=50 dyads from PACE sites  Ages 21-100 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) N=120 caregivers  [currently enrolled 150]  Ages 18+ 2023
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 Mouth Care Without a Battle (MCWB) to train personal care aids (N=48) in AL communities 720 residents with dementia, 348 AL staff, and 24 dental hygienists  [current enrollment = 1780]  Ages 18+ 2023
A video intervention to improve decision making in early-onset dementia caregivers TBD Bradford C Dickerson, Massachusetts General Hospital Video decision aids (user manuals) N=150 caregivers of those with young-onset patients (≤65) with ADRD; Ages not specified 2023
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 Savvy Caregiver program (Savvy) N=36 (dementia family caregivers); 6 in 6 groups  Ages 18+ 2022
GamePlan4Care: Web-based Delivery System for REACH II GamePlan4Care: Online Support for Family Caregivers (GP4C) Alan B Stevens, Baylor Research Institute "GamePlan4Care (GP4C)  [proof-of-concept; 2-armed]" N=240 dementia caregivers  Ages 18+ 2023
Advancing Alzheimer’s family caregiving interventions and research capacity in Vietnam TBD Walter Ladson Hinton, University of California at Davis Vietnam Resources for Enhancing Alzheimer’s Caregiver’s Health (REACH VN) 350 family caregivers 18+ 2024
Negotiation Training to Optimize Caregiver Communication in Alzheimers Disease TBD Lee A Lindquist, Northwestern University at Chicago negotiation and dispute resolution training program for caregivers with PLWD 150 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 & provider Phase 1: 20 caregivers and 6 PLWD for focus groups Phase 2: 120 dyads of caregivers PLWD 2025
A home-based, culturally and language specific intervention for dementia family caregivers: stress reduction and education with wearable technology for health TBD Jung-Ah Lee, University of California-Irvine stress reduction and dementia education intervention with werable technology to measure behavioral and physiological measures 332 adult family caregivers of PLWD 2025
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 N=114 African-American caregivers for older adults with ADRD, Ages 55+ 2021
Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes toward Dementia among Long-Term Care Nursing Assistants Certified Nursing Assistants' Wellbeing (CNA) Philip D Sloane, University of North Carolina, Chapel Hill Mindful Self-Compassion (MSC) training N=45 CNAs (3 Nursing Homes)  Ages 18+ 2021
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 adaptation of a mindfulness-based stress reduction (MBSR) N=5-8 advisory council members  Ages 21+ 2021
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 (mobile health technology) N=60 dyads Ages 65+ 2021
SPEEKO for Elderspeak: A Self-Monitoring App to Improve Communication and Do: Reduce Behavioral Symptoms in Care for Persons with Alzheimers Disease and Other Dementias Speeko for Elderspeak Kristine N Williams, University of Kansas Medical Center CHAT Training Program N= 60 from 6 Nursing Homes Ages = 18+  Phase 2:  50 dyads [N=100] 2021
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 culturally tailored text message intervention for caregiver support of individuals with dementia among Latinos Latino Caregivers of individuals with ADRD 2022
SAGE LEAF:  Reducing Burden in Alzheimer’s Disease Caregivers through Positive Emotion Regulation and Virtual Support TBD Dershung Yang, Brightoutcome, Inc SAGE LEAF N=30 Ages 18+ (no more than age 90 2022
Extending Independence And Quality Of Life For People With Alzheimers 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, UCSF Livestream virtual group program delivery to improve PLWD QOL Aim 1: 224 dyads of persons with mild ADRD and their primary caregivers Aim 2: 25-30 persons with MCI Aim 3: 10-15 current and potential Moving Together instructors 2022
Using Technology to Support Care Partners for Persons with Alzheimers Disease: Tele-STELLA Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA (Tele-STELLA) Allison Lindauer, Oregon Health & Science University telehealth-based intervention for family care partners including education and peer support to reduce BPSD 150 adult family caregivers of PLWD 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 3 nursing homes 2021
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 Indianpolis telephone intervention to teach patient-caregiver dyads problem solving, self-management and communication skills, and enhance interactions 125 staff to pilot training protocol; 1000 patients and caregivers from home healthcare service 2021