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Ongoing Alzheimers and Related Clinical Trials and Studies

Section 1: Early-Stage Clinical Drug Development

Amyloid beta
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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) 2021
Generation Study: Alzheimer’s Prevention Initiative Apolipoprotein E4 Trial A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (Generation S1) Eric Reiman and Pierre Tariot, Banner CAD106
(anti-amyloidβ immunotherapy)
CNP520
(beta-secretase inhibitor)
Cognitively healthy individuals with two copies of the APOEε4 gene (Ages 60-75) 2025
Active Immunotherapy for Cognitive Decline in Adults with Down Syndrome Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome (3 Star) Howard Feldman,
University of California San Diego
ACI-24
(anti- amyloidβ vaccine)
Down syndrome adults age (Ages 35-55) 2020
Solid oral dosage form and chronic tox for PTI-125 A Phase I Study in Healthy Volunteers Lindsay H. Burns Pain Therapeutics, Inc. PTI-125
(filamin A (FLNA), a protein critical to beta amyloid's toxicity)
Healthy volunteers (Ages 18-45) 2020
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) 2020
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) 2020
Multiple Ascending Dose clinical trial of PTI-125, a novel AD therapeutic candidate 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) 2020
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) 2022
A Seamless Phase 2A-B Randomized Double Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of PQ 912 in Patients with Early Alzheimer's Disease A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD Howard Feldman,
University of California San Diego
PQ 912 (glutaminyl cyclase (QC) inhibitor) (treats both amyloidopathy and neuroinflammation) Adults with MCI or mild probable AD (Ages 50-89) 2023
Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimer’s Disease TBD Susan Catalano, Cognition Therapeutics, Inc. CT1812
(sigma2 receptor antagonist)
Adults with Mild to Moderate Alzheimer’s Disease (Ages 50-80) 2021
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) Yassine, Hussein,
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) 2021
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
Levetiracetam (LEV)
(synaptic vesicle protein (SV2A) modulator)
Healthy adults, carriers of APOE ε4 (Ages 55-75) 2020
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) 2024
Synaptic plasticity/Neuroprotection
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 TBD Judith Kelleher-Andersson,
Neuronascent, INC.
NNI – 362
(modulates the phosphorylation of p70S6K) (drug functions as neuron regenerative therapy)
Healthy volunteers (Ages 50-72) 2020
Safety and modulation of ABCC9 pathways by nicorandil for the treatment of hippocampal sclerosis of aging (SMArT–HS) TBD Gregory A. Jicha, University of Kentucky
Peter Nelson,
University of Kentucky
Nicorandil
(agonist for sulfonyl urea receptor 2 protein (SUR2))
Adults with probable Hippocampal sclerosis (HS)-aging (Ages ≥ 75) 2024
(-)-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) 2025
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) TBD 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) 2024
Metabolism and Bioenergetics
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Benfotiamine in Alzheimer’s Disease: A pilot study Benfotiamine in Alzheimer's Disease: A Pilot Study (Benfotiamine) Gary Gibson, Burke Medical Research Institute Benfotiamine
(synthetic derivative of thiamine (Vitamin B1))
People with Mild Cognitive Impairment or Alzheimer’s disease (Ages ≥ 60) 2020
Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial of T3D-959 in Mild to Moderate Alzheimer's Disease Subjects TBD John Didsbury, T3D Therapeutics T3D-959
(PPARγ and PPARδ agonist)
Adults with mild to severe AD (Ages 50-90) 2023
Vasculature
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Hypertension, angiotensin receptor blockers, and cognition: effects and mechanism CAndesartan vs LIsinopril Effects on the BRain (CALIBREX) Ihab Hajjar, Emory University Candesartan
(angiotensin II receptor blocker)
Hypertensive adults with Mild Cognitive Impairment (Ages ≥ 60) 2020
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) 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) 2022
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) 2024
Multi-target
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Phase II RCT of High-dose Vitamin D Supplements in Older Adults without Dementia High-dose Vitamin D Supplements in Older Adults John Olichney, University of California, Davis Vitamin D
(Vitamin D receptor)
People with Mild Cognitive Impairment or mild Alzheimer’s disease (Ages 65-90) 2023
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) 2023
Inflammation
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Assessment of lenalidomide to treat Alzheimer's disease N/A 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 TBD Daniel Martin,
Watterson
Northwestern University Feinberg School of Medicine
MW151
(selectively suppress proinflammatory cytokines))
Healthy volunteers (Open to all adults meeting inclusion criteria) 2022
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) 2020
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) 2023
Other
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 TBD Nazan Aksan,
University of Iowa
Melatonin (regulates sleep cycle) Older adults (Ages 60-75) 2025
Olfactory deficits and donepezil treatment in cognitively impaired elderly Olfactory Deficits and Donepezil Treatment in Cognitively Impaired Elderly Davangere Devanand, Columbia University Donepezil
(acetylcholinesterase (AChE) inhibitor)
People with Mild Cognitive Impairment or Alzheimer’s disease (Ages 55-95) 2020
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)
2023
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) 2023
Biomarker Predictors of Memantine Sensitivity in Patients with Alzheimer's Disease Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease Neal Swerdlow,
University of California
Memantine
(noncompetitive NMDA receptor antagonist)
Mild to Moderate Alzheimer’s Disease 2025
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

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

Amyloid
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
A4 Trial
Anti-Amyloid treatment in Asymptomatic Alzheimer’s Disease
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study (LEARN) Reisa Sperling,
Brigham and Women's Hospital
Solanezumab
(anti-amyloidβ antibody)
Cognitively healthy older adults who are amyloid positive on brain imaging (Ages ≥65) 2022
Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN-TU) – Adaptive 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 Gantenerumab
(anti-amyloid β antibody)
Solanezumab
(anti-amyloidβ antibody)
Cognitively healthy or mildly impaired adults who are Alzheimer’s disease genetic mutation carriers (Open to all adults meeting inclusion criteria) 2022
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 A3 Study: Ante-Amyloid Prevention of Alzheimer's disease TBD Reisa Sperling,
Brigham and Women's Hospital; Paul Aisen Alzheimer’s Therapeutic Research Institute;
Keith Johnson, Massachusetts General Hospital
Anti-amyloid therapy TBD Cognitively healthy older adults with “non-elevated” amyloid levels on screening PET. (Ages 60–75.  Adults 60 – 65 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 and 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
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 TBD Cognitively healthy or mildly impaired adults who are Alzheimer’s disease genetic mutation carriers (Open to all adults meeting inclusion criteria) 2024
Neuroprotection
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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) 2021
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) Adults with amnestic Mild Cognitive Impairment (Ages 55-85) 2023

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Section 3: Non-Pharmacological Interventions

Exercise
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
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
Effect of Aerobic Exercise on Alzheimer's Pathophysiology in Preclinical AD Alzheimer's Prevention Through Exercise (APEx) Jeffery Burns, University of Kansas Aerobic exercise training Cognitively healthy older adults who are amyloid positive on brain imaging (Ages ≥ 65) 2020
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) 2020
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 N/A Steven Verney,
University of New Mexico
Interactive Metronome (IM) therapy American Indians (Ages 68 to 80) 2020
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
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 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) 2024
Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults with Mild Cognitive Impairment N/A Sarah McEwen,
John Wayne Cancer Institute
Aerobic exercise and memory skills training program Adults with amnestic MCI (Ages 65-80) 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) FREDRIKSEN-GOLDSEN, KAREN ILENE (contact); TERI, LINDA
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
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) VERGHESE, JOE
Albert Einstein College of Medicine, Inc
Social (ballroom) dancing and active control (walking) interventions N=32 adults
Ages 65+
2020
Effects of mindful Feldenkrais exercises & strength training on cognitive executive function in independent living older adults N/A ULLMANN, GERHILD
The University of Memphis
The Feldenkrais Method 108 older adults age 65-85 2021
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
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 2021
Mindfulness Training for Mitigating Age-Related Cognitive Decline in the Elderly Mind-body Interventions for Healthy Aging (HealthyAgers) Prakash, Ruchika
Ohio State University
Mindfulness training Adults aged 65-85 2022
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 2019
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
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
Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults TBD Fuzhong Li,
Oregon Research Institute
Tai Ji Quan Adults with amnestic MCI (Ages ≥ 65)
Combination Therapy
2025
Diet
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) 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
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) 2024
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
Omega 3 Pufas for the Vascular Component of Age-Related Cognitive Decline n-3 PUFA for Vascular Cognitive Aging Lynne Shinto Gene Bowman
Oregon Health & Science University
Omega 3 polyunsaturated fatty acids (pufas) 80 years and older 2019
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
Cognitive Training
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Cognitive training and practice effects in MCI Cognitive Training and Practice Effects in MCI Kevin Duff, University of Utah Computerized cognitive training People with Mild Cognitive Impairment (Ages ≥ 65) 2020
Processing Speed Training to Preserve Driving and Functional Competencies in MCI N/A Virginia Bradley, University of Alabama at Birmingham Computerized processing speed training People with Mild Cognitive Impairment (No age restriction) 2020
Plasticity-based Adaptive Cognitive Remediation for Alzheimer’s Disease Phase II Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging) Lee, Hyun Kyu Plasticity, Inc 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) 2022
Cognitive training and neuroplasticity in mild cognitive impairment Cognitive Training and Neuroplasticity in Mild Cognitive Impairment (CogTraining) Davangere P. Devanand,
Columbia University
Computerized cognitive training People with Mild Cognitive Impairment (Ages 55-95) 2023
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) 2020
Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia Emily Rogalski,
Northwestern University
Personalized speech-language therapy intervention Individuals with Mild Primary Progressive Aphasia (Ages ≥ 30) 2023
Optimizing Cognitive Assessment in DIAN with Smartphone-based burst testing N/A Jason Hassenstab,
Washington University
Smartphones Cognitively healthy or mildly impaired adults who are Alzheimer’s disease genetic mutation carriers 2024
Cognitive Regulation Training and Exercise (CORTEX)-II with Middle-aged Adults Cognitive Regulation Training and Exercise Trial (CORTEX-II) MULLEN, SEAN P
University of Illinois at Urbana-Champaign
CORTEX 250 participants (ages 35-64) 2021
Interventions to Attenuate Cognitive Decline Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp EDWARDS, JERRI
University of South Florida
Intense piano training 200 participants at least 60 years of age 2020
Boosting Older Adults Cognition by Training Real-World eHealth Skill N/A XIE, BO
The University of Texas at Austin
Elaborative encoding strategy (retrospective memory); implementation intentions (prospective memory); collaborative learning program 98 older adults (65+) 2020
Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia N/A EDWARDS, JERRI
University of South Florida
Combinations of cognitive training exercises Participants N = unclear
Ages 65-89
2020
Preventing Alzheimer’s Disease with Cognitive Training: The PACT Trial Preventing Alzheimer's Disease with Cognitive Training (PACT) EDWARDS, JERRI
University of South Florida
Cognitive speed of processing training (SPT) N=7600; Ages 65+ 2019
Elucidating the Necessary Components and Mechanisms of Cognitive Training N/A ROSS, LESLEY A
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
2020
Videogame-based environmental enrichment training for altercations in hippocampal function and memory in middle-aged adults N/A STARK, CRAIG E
UC Irvine
Minecraft Complexity (incr. complexity/decr. spatial),
Minecraft Spatial (decr. complexity/incr. spatial)
105 naive video gaming, healthy volunteers (35 per group), ages 40-49 2020
Enhancing Cognitive Control in Older Adults with Complementary Interventions N/A GAZZALEY, ADAM H
UCSF
Externally-oriented attention training (AT) and internally oriented meditation training (MT) Ages 60+: 225 older adults (local sample); 1650 older adults (national sample)
Ages 18-29: 50 younger adults (local sample)
2020
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) CLARK, DANIEL O.
Indiana University
High polyphenol (MIND) foods combined with speed of processing cognitive training 180 older adults (60+) 2022
Working Memory Training in Older Adults N/A JAEGGI, SUSANNE MADLAINA
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
2019
Developing and testing a neurotherapeutic treatment to improve spatiotemporal cognition in seniors N/A ARONSON, THEODORE
COGNIVIVE, INC.
BrainPixel 10 healthy seniors aged Ages 65-85 2020
Applying Person-Centered Approach to Enhance Cognitive Training in Assisted Living Facility Residents with Mild Cognitive Impairment Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents with Mild Cognitive Impairment (CogT-PACT) LIN, FENG VANKEE
University of Rochester School of Nursing
Computerized cognitive interventions (CCIs) 50 MCI residents from Assisted Living facilities, aged ≥65 2020
Strategic Training to Optimize Neurocognitive Functions in Older Adults N/A BASAK, CHANDRAMALLIKA
The University of Texas at Dallas
Increasing attentional control demands 26 older adults (55-85) 2019
Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults Richard Kennedy University of Alabama at Birmingham speed of processing training (lab and home tablet based) 65 years and older, positive delirium screen following admission to inpatient University of Alabama at Birmingham Hospital 2022
Combination Therapy
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) 2020
Memory Lane: A neuro-exergame to mitigate cognitive decline in later life The Interactive Physical and Cognitive Exercise System (iPACES™) Emilie Saulnier, 1st Playable Productions
Cay Anderson-Hanley, Union College
Interactive physical and mental exercise (cybercycling) Healthy older adults (Ages ≥ 50) 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) 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) 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) 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) 2024
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 2022
Diet and Exercise Trial to Improve Insulin Resistance, Increase Cerebral Blood Flow, Alter Metabolomic Biomarkers, and Decrease Alzheimers Disease Risk Study: Diet and Exercise Study to Improve Brain Blood Flow: Blood Flow Improvement Trial (BFIT) Randall J Gretebeck,
University of Wisconsin, Madison
diet and exercise program Older adults aged 45-65 2019
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
Partnered Rhythmic Rehabilitation for Enhanced Motor-Cognition in Prodromal Alzheimer's Disease TBD Madeleine E. Hackney,
Emory University
Partnered Rhythmic Rehabilitation Adults with prodromal AD (Ages 50-80) 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 2023
Sleep
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Changing the Trajectory of Mild Cognitive Impairment with CPAP Treatment of Obstructive Sleep Apnea MCI: CPAP Treatment of OSA (Memories2) (MCI:OSA) Nalaka Gooneratne, University of Pennsylvania Continuous positive airway pressure (CPAP) People with obstructive sleep apnea and amnestic Mild Cognitive Impairment
(Ages 55-75)
2022
Primary Prevention of Alzheimer's disease: Examining the effects of cognitive behavioral therapy on cognitive function and amyloid-beta in older adults with symptoms of insomnia SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid Catherine Siengsukon,
University of Kansas Medical Center
Cognitive behavioral therapy for insomnia (CBT-I) People with difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights per week for the past 3 months, (Ages 60-85) 2024
A Dyadic Sleep Intervention for Alzheimer’s Disease Patients and Their Caregivers A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers SONG, YEONSU
UCLA
Behavioral sleep intervention program 40 AD patient-caregiver dyads, 60+ 2022
Napping, Sleep, Cognitive Decline and Risk of Alzheimer’s Disease Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease LENG, YUE
UCSF
Bright light therapy (BLT) and cognitive behavioral therapy for insomnia (CBT-i) 40 older adults (aged 65+) with MCI or mild Alzheimer’s disease 2019
The feasibility of a tailored music intervention to reduce symptoms of sleep disruption in older adults with dementia N/A PETROVSKY, DARINA
Environment and Health Group, Inc.
Home-music intervention 60 dyads (older adults with ADRD and their caregivers), Ages 60+ 2021
Other
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Hyperbaric oxygen therapy for cognition in diabetic elderly at high dementia risk Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk Michal Schnaider Beeri, Icahn School of Medicine at Mount Sinai
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, University of Kentucky
Gregory Jicha, University of Kentucky
Medication management Non-demented older adults (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) 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) 2023
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) 2024
Investigating dementia worry and its impact on older adults N/A MAXFIELD, MOLLY
UNIVERSITY OF COLORADO AT COLORADO SPGS
Optimistic empirically
supported information on both how dementia risk can be minimized and how planning can minimize its negative effects on self and others
590 participants; middle-aged (41-60); older adults (65-90) 2020
Decisions about Cancer Screening in Alzheimer’s Disease N/A FOWLER, NICOLE R
Indiana University
Mammography decision aid 426 dyads consisting of an older woman with AD and a family caregiver; ages 75+ 2022
Improving advance care planning for seniors at risk for Alzheimer’s disease and related dementias and their caregivers Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE) SUDORE, REBECCA L
Northern California Institute for Research and Education
PREPARE 24 cognitively impaired 55+ adults and 24 caregivers 2020
Preparation for End of Life Decision Making in Mild Alzheimer’s Disease Two-Phased Study of SPIRIT in Mild Dementia SONG, MI-KYUNG
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 N/A BETZ, MARIAN ELIZABETH
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 N/A LINDQUIST, LEE A
Northwestern University
Plan Your Lifespan 300 older adults 55+ 2024
Motor Imagery: A Pilot Intervention for Improving Gait and Cognition in the Elderly Motor Imagery Intervention for Improving Gait and Cognition in the Elderly Helena Blumen
Albert Einstein College of Medicine of Yeshiva University
Imagined gait 65-85 years old, community dwelling older adults 2020
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) 2020
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) 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) 2024
Cognitive Enhancement Through Transcranial Laser Therapy Cognitive Enhancement Through Transcranial Laser Therapy (LLLT) Andrena Haley
The University of Texas at Austin
Low Level Light/Laser Therapy (LLLT) 30 men and 30 postmenopausal women, aged 45-65 2020
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, 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 2020
Assistive Technology/Device
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Accurate WiFi-Based Localization of Dementia Patients for Caregiver Support Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support SHEIKH, SUNEEL ISMAIL
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
2020
Automated Social Interactive Interface to Monitor and Update Intervention Plans for People with MCI, Alzheimer’s and Other Dementias N/A HAVEY, GARY D
Advanced Medical Electronics Corp.
Social interactive interface (SII) + SimpleC platform Age ranges: 20-40; 40-65; 65+
Phase 1: Study A has 14 dyads
Phase 2:
Study B – 7 dyads
Study C – 14 dyads
Study D – 60 dyads
2019
A Randomized Controlled Trial of Visual Cues, Signage, and Spaced-Retrieval Education within Long Term Care Communities to Assist with Wayfinding N/A DAVIS, REBECCA
Grand Valley State University
Assistive cues plus education N=137 residents from 12 senior AL facilities; Ages 62+ 2023
My MESSAGE: Improving Wayfinding and Reducing Challenging Behaviors in Persons with Dementia Through the Use of RFID Technology N/A ZEISEL, JOHN
Hearthstone Alzheimer Care
My MESSAGE System 24 persons with dementia, ages 65+ 2021
Digital multidomain lifestyle intervention to address cognitive health and modifiable risk factors for Alzheimer's disease N/A BOTT, NICHOLAS
Neurotrack Technologies, Inc.
Digital multi-domain AD risk reduction intervention 200 at-risk adults age 45-64 2019
Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers In-Home Technology for Dementia Caregivers WANG, GENE
People Power Company
In-home technology 80 caregivers for PWDs (21+) 2021
Accessible Hearing Care for Reduction of Disruptive Behaviors and Caregiver Burden in Dementia N/A NIEMAN, CARRIE L
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
Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Frank Lin, Josef Coresh
Johns Hopkins University
Hearing aid 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 Stapleton, Renee Needham, Dale Murray
HEALTHY DESIGN, LTD. CO.
Novel Arm Restraints Adults 65 or older who are critically ill 2021

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

Pharmacological
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Treatment of psychosis and agitation in Alzheimer’s disease Treatment of Psychosis and Agitation in Alzheimer's Disease Davangere Devanand, Columbia University Lithium
(GSK3α and GSK3β inhibitor)
People with Alzheimer’s disease and agitation/aggression (No age restriction) 2020
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, 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) 2020
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) 2022
Pilot Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer’s Disease Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD) Paul Rosenberg, 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
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
Non-Pharmacological
Project Name Trial Name on CT.gov Principal Investigator/ Institution Intervention Population Anticipated Completion Date
Reducing Agitation in Dementia Patients at Home: The Customized Activity Trial Reducing Agitation in People With Dementia: the Customized Activity Trial (TAP) Laura Gitlin, Johns Hopkins University Patient customized activity People with dementia and a family caregiver (Open to all adults meeting inclusion criteria) 2021
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) 2022
A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimers Dementia (ECT-AD) Electroconvulsive Therapy (ECT) for Agitation in Alzheimer's Dementia (AD) Brent Peter Forester, McLean Hospital
Georgios Petrides, Zucker Hillside Hospital
Electroconvulsive Therapy People with moderate to severe stage Alzheimer’s Disease (Ages ≥ 55) 2024

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Section 5: Care and Caregiver Interventions

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
Translation of COPE for Publicly-Funded Home Care Clients and their Families Translation of COPE for Publicly-Funded Home Care Clients and Their Families (COPECT) FORTINSKY, RICHARD H
University of Connecticut
Care of Persons with Dementia in their Environments (COPE) 290 dyads of clients with dementia 65+ and their CGs in a combined Medicaid waiver and state revenue-funded home care program 2019
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) GITLIN, LAURA N
Johns Hopkins University
Adult day service (ADS) Plus 300 caregivers 21+ initially enrolling their relative in one of the 30 ADS sites 2021
The Care Ecosystem: Navigating patients and caregivers through stages of dementia care Care Ecosystem: Navigating Patients and Families Through Stages of Care POSSIN, KATHERINE LAUREL
UCSF
Care Ecosystem 1050 persons with dementia 45+ and caregiver dyads 2023
METRIcAL - Music & MEmory: A Pragmatic TRIal for Nursing Home Residents with ALzheimers Disease Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL) MOR, VINCENT
Brown University
MUSIC & MEMORY (M&M) Music Program 66 Nursing Home facilities 2022
Palliative care needs and outcomes for dementia patients N/A PERIYAKOIL, VYJEYANTHI S
Stanford University
Usual care plus an early palliative care intervention (EPC) N=200 Stanford ADRC participants
Ages 60-100
2023
LEAD IT! An App to Enable Persons with Early Stage Dementia to Lead Group Activities for Their Peers N/A SKRAJNER, MICHAEL JOHN
Hearthstone Alzheimer Care, LTD
LEAD IT! (tablet-based app) 24 persons with dementia 65+ (i.e., 20 player-participants and 4 resident leaders) 2018
Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer’s Dementia Risk Disclosure N/A RAHMAN-FILIPIAK, ANNALISE MARIE
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
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 TOWSLEY, GAIL L
University of Utah
Me & My Wishes (videos of nursing home residents talking about their preferences for care) 54 nursing home residents 65+ 2020
Building a Bridge (between clinical and community care): Post-diagnosis support of persons with dementia and their family) N/A ASHIDA, SATO
University of Iowa
Options Counselor-Health Education (OC-HE) 80 family members of someone recently diagnosed with ADRD 18+ 2020
A health monitoring tool for dementia care management N/A MISH, PATRICK
Dementia Care Management, Inc.
Web/mobile version of MIND at Home 20 residents in a continuing care retirement community 2019
Changing Talk Online (CHATO): A Pragmatic Trial to Reduce Behavioral Symptoms in Dementia Care Changing Talk Online (CHATO) Study WILLIAMS, KRISTINE
University of Kansas Medical Center
Changing Talk Online (CHATO) 150 nursing home staff members (18+) 2020
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) REUBEN, DAVID
University of California, Los Angeles
Health system-based and community-based dementia care 2150 dyads of persons with dementia and their primary caregivers (18+) 2020
Pragmatic Trial to Improve Communication for Primary Care Patients with ADRD N/A WOLFF, JENNIFER L
Johns Hopkins University
Sharing Choices Patients 65+ in 100 primary care clinics 2020
The Hospice Advanced dementia Symptom Management and Quality of Life Trial (HAS-QOL) N/A BRODY, ABRAHAM AIZER
New York University
Dementia Symptom Management at Home Program Hospice Edition 25 hospice agencies 2019
PCplanner: operationalizing needs-focused palliative care for older adults in intensive N/A COX, CHRISTOPHER ETHAN
Duke University
PCplanner 250 older adults ≥65 managed in an ICU and their family members 2024
Reducing Risk of Dementia through De-prescribing (R2D2) N/A CAMPBELL, NOLL L.
Purdue University
Pharmacist-driven de-prescribing protocol 344 older adults 65+ 2024
MIND: An RCT of care coordination for community-living persons with dementia MIND: Care Coordination for Community-living Person With Dementia (MIND at Home) Quincy Samus, Johns Hopkins University Home based care coordination People with Alzheimer’s disease and family caregiver (Open to all adults meeting inclusion criteria) 2020
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) 2023
Triggered Palliative Care for Advanced Dementia: A Pilot Study Triggered Palliative Care for Advanced Dementia Laura C. Hanson.
University of North Carolina
Palliative care People with advanced dementia (Ages ≥ 65) 2019
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) 2024
Indiana University Dementia Screening Trial: The IU CHOICE Study Indiana University Dementia Screening Trial (IU-CHOICE) Malaz Boustani
Indiana University
Dementia Screening and collaborative care People attending urban primary care (Ages ≥ 65) 2020
Online Training & Certification for Competency in Dementia Friendly Hospital Care N/A HOBDAY, JOHN V (contact); MITTELMAN, MARY SHERMAN
HealthCare Interactive, Inc.
Hospital Training and Certification Technology (HTCT) 12 hospitals (at least 33 participants per site) 2019
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living TERESI, JEANNE A (contact); LACHS, MARK STEVEN; PILLEMER, KARL A
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 N/A GILMORE-BYKOVSKYI, ANDREA L
University of Wisconsin-Madison
Tailored clinical trial registry recruitment 30 patient/caregiver dyads 65+ 2023
Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design N/A Natalie Regier
Johns Hopkins University
Service user-led meaningful activity intervention People that are mild or in the early stages of dementia
(Ages ≥ 60)
2024
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
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 HEPBURN, KEN W (contact); GRIFFITHS, PATRICIA C
Emory University
Tele-Savvy 216 informal caregivers (family/friends) 18+ of persons living with Alzheimer’s 2020
A video intervention to improve decision making in early-onset dementia caregivers N/A DICKERSON, BRADFORD C
Massachusetts General Hospital
Video decision aids (user manuals) N=150 caregivers of those with young-onset patients (≤65) with ADRD; Ages not specified 2023
Community-based End-of-life Intervention for African American Dementia Caregivers End-of-life Intervention for African American Dementia Caregivers BONNER, GLORIA J
University of Illinois at Chicago
Education Activation (EduAct) intervention 304 AA healthcare proxies (HCPs) 18+ for persons with dementia 2019
The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers N/A FIELDS, NOELLE
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 N/A HEPBURN, KEN W
Emory University
Savvy Caregiver program (Savvy) N=36 (dementia family caregivers); 6 in 6 groups
Ages 18+
2022
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 N/A HODGSON, NANCY A
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
STAR Caregivers - Virtual Training and Follow-up N/A PENFOLD, ROBERT B
Kaiser Foundation Research Institute
STAR Virtual Training and Follow-up (STAR- VTF) N=100 caregiver-PWD dyads
Ages ≥55
2022
Adapting an Evidence-Based Program that Improves Oral Hygiene and Health for Assisted Living Residents with Dementia Oral Hygiene in Assisted Living ZIMMERMAN, SHERYL
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
Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes toward Dementia among Long-Term Care Nursing Assistants Certified Nursing Assistants' Wellbeing (CNA) SLOANE, PHILIP D
University of North Carolina, Chapel Hill
Mindful Self-Compassion (MSC) training N=45 CNAs (3 Nursing Homes)
Ages 18+
2020
Decide, Discover, and Do: An Intervention for Community-Dwelling Older Adults with Alzheimer’s and Other Dementias N/A GORZELLE, GREGG
Hearthstone Alzheimer Care, LTD
Decide, Discover, and Do (D3)! - software application (interactive, video-based series of education courses and activities) Phase 1:
20 participants (10 persons with dementia/family caregivers dyads)
PWD = 55+
Phase 2:
50 dyads [N=100]
2019
The Residential Care Transition Module The Residential Care Transition Module (RCTM) GAUGLER, JOSEPH E.
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
Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families N/A GAYLORD, SUSAN
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
Cognitive training to protect immune systems of older caregivers Cognitive Training for Older Caregivers (CTC) HEFFNER, KATHI L
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
Web-based Behavioral Activation for Alzheimer’s Caregivers N/A MAUSBACH, BRENT T
UCSD
Web-Based Behavioral Activation (wBA) 44 dementia caregivers 21+ 2019
Mindfulness based stress reduction for family caregivers of dementia patients Improving Well-Being for Older Adult Family Dementia Caregivers MOYNIHAN, JAN A
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
Mobile, Web-based Behavioral Intervention for Improving Caregiver Well-being Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being MAUSBACH, BRENT T
University of California, San Diego
Behavioral Activation (BA) - mobile intervention N=200 dementia caregivers
Ages 40+
2023
LEAF 2.0: Randomized trial of a technology-based positive emotion intervention for informal caregivers of individuals with Alzheimer’s disease N/A MOSKOWITZ, JUDITH T
Northwestern University of Chicago
LEAF, Life Enhancing Activities for Family caregivers (3-arm technology-based RCT) N=500 caregivers
Ages 34-87
2023
Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention (CGMI-V) PAUN, OLIMPIA
Rush University Medical Center
Chronic Grief Management: A Live Streaming Video, Online Intervention N=93 ADRD caregivers
Ages 60+
2021
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) UTZ, REBECCA LYNN
University of Utah
Time for Living & Caring (TLC) N=120 caregivers
Ages 18+
2023
GamePlan4Care: Web-based Delivery System for REACH II N/A STEVENS, ALAN B
Baylor Research Institute
"GamePlan4Care (GP4C)
[proof-of-concept; 2-armed]"
N=240 dementia caregivers
Ages 18+
2023
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms N/A IRWIN, MICHAEL R
UCLA
Mindful Awareness Practices for Insomnia (MAP-I) 150 AD spousal caregivers 60+ 2022
Mindfulness-based Cognitive Coping Mobile App Intervention for caregivers of individuals with Alzheimer’s Disease N/A KAJIYAMA, BRUNO
Photozig, Inc.
Mindfulness-based Cognitive Coping (MCC) Mobile App 25 dementia caregivers 18+ 2018
A mobile self-compassion intervention for Hispanic Dementia Caregivers N/A KAJIYAMA, BRUNO
Photozig, Inc.
Self-Compassion Coping intervention for dementia caregivers (SCC) - mobile application 25 Hispanic/Latino caregivers
18+
2020
Stress resilience and aging in Alzheimer’s disease and dementia caregivers N/A CROSSWELL, ALEXANDRA DUPONT
University of California, San Francisco
Expressive writing 60 family caregivers of Alzheimer’s disease and dementia patients 50+ 2023
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals with Alzheimer Disease and Related Dementias N/A YANK, VERONICA
University of California, San Francisco
Building Better Caregivers 640 rural dementia caregivers 18+ 2023
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) CZAJA, SARA J
University of Miami
Dyadic cognitive/functional training intervention 240 dyads of individuals with mild AD and their CGs 21+ 2022
Alzheimer Caregiver Coping: Mental and Physical Health Alzheimer's Caregiver Coping: Mental and Physical Health GRANT, IGOR (contact); MAUSBACH, BRENT T
University of California San Diego
Behavioral Activation (BA) 200 spousal CG 55+ providing care at home 2019
Utilizing Senior Companions to Enhance Dementia Care Services and Supports Utilizing Senior Companions to Enhance Dementia Care GAUGLER, JOSEPH E
University of Minnesota
Adaptation of the Senior
Companion Program (SCP)
R61 Phase: N=25 PWD
R33 Phase: N=250 PWD
Ages 21-102
2020
Hip Fracture Caregiver Intervention Function Focused Care Hip Care at Home Function Focused Care: Fracture Care at Home GRUBER-BALDINI, ANN L
University of Maryland
Function Focused Care for the Cognitively Impaired: Hip Care at Home (FFC-HC) 20 hip fracture patients with ADRD 65+ and their informal caregivers 2019
Tools for Coordination Among Caregivers of Patients with Alzheimer’s Disease and Other Dementias N/A HAVEY, GARY D
Advanced Medical Electronics Corp.
SimpleC Companion 30 individuals with dementia 65+ (10 each with mild, moderate, or severe) and their caregivers 2020
Adapting and testing an Alzheimer’s family caregiver intervention in Vietnam Alzheimer's Family Caregiver Intervention in Vietnam HINTON, WALTER LADSON (contact); NGUYEN, HUONG
UC Davis
Vietnamese version of REACH-VA 30 dyads of patients 21+ diagnosed with dementia and their family caregivers 2019
A Culturally-relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population Vietnamese Caregiver Intervention Study MEYER, OANH L
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+ 2020
Old SCHOOL Hip Hop: A randomized controlled trial to improve dementia knowledge Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge NOBLE, JAMES MCCALLUM
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 N/A FOWLER, NICOLE R
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 N/A RIFFIN, CATHERINE
Weill Medical College of Cornell University
Caregiver screening-referral protocol for primary care 45 patient-caregiver dyads (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) 2024

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