NIA-Funded Active Alzheimer’s and Related Dementias Clinical Trials and Studies
Page last updated: December 4, 2020
The National Institute on Aging (NIA) is currently supporting 233 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.
On this page:
- Section 1: Early-Stage Clinical Drug Development (46 trials)
- Section 2: Late-stage Clinical Drug Development (Phase II/III and III Clinical and Pragmatic Trials) (13 trials)
- Section 3: Non-Pharmacological Interventions (123 trials)
- Section 4: Clinical Therapy Development for the Neuropsychiatric Symptoms of Dementia (6 trials)
- Section 5: Care and Caregiver Interventions (84 trials)
Section 1: Early-Stage Clinical Drug Development
| 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) | 2020 |
| 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 |
| 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) | 2021 |
| 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 |
| 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 |
| 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) | 2021 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| NAD+ therapy for improving memory & cerebrovascular function in patients with MCI Top of Form Bottom of Form | 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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) | 2021 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| (-)-Phenserine Inhibition Of Neuronal Death In Alzheimer’S Disease And Developing Brain-Labeled Plasma Exosomes Assays As Biomarkers For A Phenserine Phase 1B Ascending Dose Trial | TBD | Lon S. Schneider, University of Southern California | (-)-PHENSERINE (Inhibits neuronal pre-programmed cell death) | Adults with probable AD (Ages 70-82) | 2024 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 2020 |
| 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 and III Clinical and Pragmatic Trials)
| 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 |
| 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 |
| 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 | 2021 |
Section 3: Non-pharmacological Interventions
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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) | 2021 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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+) | 2021 |
| 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 |
| 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 |
| 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 |
| 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 | Daniel Bateman, Indiana University-Purdue University at Indianapolis | Smartphone-based ecological momentary assessment (EMA) | 96 AD patient-caregiver dyads Age is 18+ (caregiver) | 2024 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 2020 |
| 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 |
| 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 |
| 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 |
| 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. | 2020 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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) | 2021 |
| 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 |
| 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 |
| COcoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind) | 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 | 2021 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| Creating a Faith-Based Toolbox for African Americans Living with Moderate and Severe Dementia | Faith-Based Toolbox for African Americans With Dementia | Fayron Recha Epps, Emory University | Taith-based home activity toolkit (Faith-HAT) | 30 PWD and caregiver dyads (ages 18+) | 2023 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 sStimulation 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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) | 2021 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Section 4: Clinical Therapy Development for the Neuropsychiatric Symptoms of Dementia
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in 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 |
| 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 |
| 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 |
| 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 |
| 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 | 2021 |
Section 5: Care and Caregiver Interventions
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| Improving Outcomes for Family Caregivers and Older Adults with Complex Conditions: The Adult Day Service Plus Program | Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program (ADS Plus) | Laura N Gitlin, Johns Hopkins University | Adult day service (ADS) Plus | 300 caregivers 21+ initially enrolling their relative in one of the 30 ADS sites | 2021 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 2021 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) | 2020 |
| 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 | 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+ | 2020 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| Indiana Palliative Excellence in Alzheimer Care Efforts-RCT | Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) | Greg Sachs, Indiana University-Purdue University at Indianapolis | Palliative care | People with moderate to severe stage dementia (Ages ≥65) | 2023 |
| 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 |
| Project Name | Trial Name on CT.gov | Principal Investigator/ Institution | Intervention | Population | Anticipated Completion Date |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| CommunityRx-Dementia | CommunityRx for Caregivers (CRx-C) | Stacy Tessler Lindau, University of Chicago | CommunityRx-Dementia (CRx-D) | 344 caregivers 18+ | 2024 |
| PLAN: Dementia Literacy Education and Navigation for Korean Elders with Probable Dementia and their Caregivers | PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers (PLAN) | Hae-Ra Han, Johns Hopkins University | PLAN (dementia literacy training) | 288 patient/caregiver dyads Patient: Ages 65+ Caregiver: Ages 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 |
| 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 |
| 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 |