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NCT07033494PHASE2Recruiting

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Merck Sharp & Dohme LLC

Start Date

7/16/2025

Completion Date

4/30/2029

Summary

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it

Eligibility Criteria

Age Range: 50 years to 85 years

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD) * Has a designated study partner who can fulfill the requirements of this study * If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a known history of stroke or cerebrovascular disease * Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically * Has structural brain disease * Has a history of seizures or epilepsy within 5 years before screening * Has any other major central nervous system trauma, or infections that affect brain function * Has major medical illness or unstable medical condition within 3 months before screening * Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality * Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study * Has a bleeding disorder that is not under adequate control * Has a history of malignancy occurring within 5 years of screening * Has a risk factor for corrected QT interval (QTc) prolongation * Has liver disease * Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan * Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

Interventions

BIOLOGICAL

MK-2214

DRUG

Placebo

Interested in This Trial?

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Conditions

Early Alzheimer's Disease

Locations

Irvine Clinical Research ( Site 1041)

Irvine, California 92614

United States

Healthy Brain Clinic ( Site 1005)

Long Beach, California 90804

United States

Inglewood Clinical ( Site 1062)

Los Angeles, California 90056

United States

Anderson Clinical Research ( Site 1024)

Redlands, California 92374

United States

UCSF Memory and Aging Center ( Site 1031)

San Francisco, California 94158

United States

Syrentis Clinical Research ( Site 1001)

Santa Ana, California 92705

United States

Yale University, Alzheimer's Disease Research Unit ( Site 1059)

New Haven, Connecticut 06510

United States

JEM Research Institute ( Site 1046)

Atlantis, Florida 33462

United States

Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

Fort Myers, Florida 33912

United States

K2 Medical Research ( Site 1047)

Maitland, Florida 32750

United States

ClinCloud LLC ( Site 1039)

Melbourne, Florida 32940

United States

Indago Research and Health Center Inc ( Site 1044)

Miami Lakes, Florida 33016

United States

Aqualane Clinical Research ( Site 1035)

Naples, Florida 34105

United States

Suncoast Clinical Research ( Site 1007)

New Port Richey, Florida 34652

United States

Renstar Medical Research ( Site 1012)

Ocala, Florida 34471

United States

Charter Research - Orlando ( Site 1051)

Orlando, Florida 32803

United States

Axiom Brain Health ( Site 1029)

Tampa, Florida 33609

United States

K2 Medical Research ( Site 1020)

Tampa, Florida 33634

United States

Charter Research - Lady Lake ( Site 1019)

The Villages, Florida 32162

United States

Conquest Research LLC ( Site 1053)

Winter Park, Florida 32789

United States

CenExel iResearch, LLC ( Site 1015)

Decatur, Georgia 30030

United States

Alexian Brothers Medical Center-Neurosciences ( Site 1017)

Elk Grove Village, Illinois 60007

United States

Boston Center for Memory ( Site 1008)

Newton, Massachusetts 02459

United States

Clinical Research Professionals ( Site 1004)

Chesterfield, Missouri 63005

United States

The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)

Ridgewood, New Jersey 07450

United States

The Cognitive and Research Center of NJ ( Site 1057)

Springfield, New Jersey 07081

United States

CenExel- AMRI ( Site 1018)

Toms River, New Jersey 08755

United States

Alzheimer Disease Research Center (ADRC) ( Site 1000)

Albany, New York 12208

United States

Mid Hudson Medical Research ( Site 1050)

New Windsor, New York 12553

United States

Basil Clinical ( Site 1065)

Queens, New York 11413

United States

AMC Research, LLC ( Site 1006)

Matthews, North Carolina 28105

United States

Insight Clinical Trials ( Site 1011)

Independence, Ohio 44131

United States

Neuro-Behavioral Clinical Research ( Site 1028)

North Canton, Ohio 44720

United States

Flourish Research ( Site 1048)

Plymouth Meeting, Pennsylvania 19462

United States

Gadolin Research ( Site 1032)

Beaumont, Texas 77702

United States

Horizon Clinical Research Center - Houston ( Site 1026)

Cypress, Texas 77429

United States

Organizacion Medica de Investigacion ( Site 0401)

Ciudad de Buenos Aires, Buenos Aires F.D. C1015ABO

Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404)

Ciudad de Buenos Aires, Buenos Aires F.D. C1431FWO

Argentina

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)

Caba, C1428AQK

Argentina

Southern Neurology ( Site 0306)

Kogarah, New South Wales 2217

Australia

KARA Institute for Neurological Diseases ( Site 0302)

Macquarie Park, New South Wales 2113

Australia

Austin Health ( Site 0300)

Ivanhoe, Victoria 3079

Australia

HammondCare ( Site 0301)

Malvern, Victoria 3144

Australia

Cliniques universitaires Saint-Luc ( Site 3001)

Brussels, Bruxelles-Capitale, Region de 1200

Belgium

UZ Leuven ( Site 3000)

Leuven, Vlaams-Brabant 3000

Belgium

AZ Groeninge Campus Kennedylaan ( Site 3002)

Kortrijk, West-Vlaanderen 8500

Belgium

Ottawa Memory Clinic ( Site 2001)

Ottawa, Ontario K1Z 1G3

Canada

Sunnybrook Research Institute ( Site 2003)

Toronto, Ontario M4N 3M5

Canada

Toronto Western Hospital ( Site 2004)

Toronto, Ontario M5T 2S8

Canada

Clinique Mémoire de Montreal ( Site 2000)

Montreal, Quebec H3G 1H9

Canada

National Center for Geriatrics and Gerontology ( Site 9002)

Ōbu, Aichi-ken 474-8511

Japan

Chibaken Saiseikai Narashino Hospital ( Site 9000)

Narashino, Chiba 275-8580

Japan

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)

Kawasaki, Kanagawa 210-0852

Japan

Mie University Hospital ( Site 9011)

Tsu, Mie-ken 514-8507

Japan

Katayama Medical Clinic ( Site 9005)

Kurashiki, Okayama-ken 710-0813

Japan

National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)

Kanzaki-gun, Saga-ken 8420192

Japan

Tokyo Medical University Hospital ( Site 9003)

Shinjuku, Tokyo 160-0023

Japan

Inage Neurology and Memory Clinic ( Site 9001)

Chiba, 263-0043

Japan

Kyushu University Hospital ( Site 9010)

Fukuoka, 812-8582

Japan

Okayama City General Medical Center Okayama City Hospital ( Site 9008)

Okayama, 700-8557

Japan

Brain Research Center Den Bosch B.V. ( Site 5001)

's-Hertogenbosch, North Brabant 5223 LA

Netherlands

Brain Research Center. ( Site 5000)

Amsterdam, North Holland 1081 GN

Netherlands

Brain Research Center Zwolle ( Site 5002)

Zwolle, Overijssel 8025 AZ

Netherlands

National Neuroscience Institute ( Site 0101)

Singapore, Central Singapore 308433

Singapore

Tan Tock Seng Hospital ( Site 0102)

Singapore, Central Singapore 308433

Singapore

Hanyang University Hospital ( Site 0200)

Seoul, 04763

South Korea

Samsung Medical Center ( Site 0202)

Seoul, 06351

South Korea

Ewha Womans University Seoul Hospital ( Site 0201)

Seoul, 07804

South Korea

Hospital Universitari Mutua Terrassa ( Site 6004)

Terrassa, Barcelona 08222

Spain

Fundació ACE ( Site 6003)

Barcelona, Catalonia 08028

Spain

Hospital del Mar ( Site 6001)

Barcelona, 08003

Spain

Hospital Clinic i Provincial ( Site 6002)

Barcelona, 08036

Spain

Scottish Brain Sciences Aberdeen ( Site 8001)

Aberdeen, Aberdeen City AB25 2XE

United Kingdom

Scottish Brain Sciences ( Site 8000)

Edinburgh, Edinburgh, City of EH12 5PJ

United Kingdom

Moorgreen Hospital ( Site 8004)

Southampton, Hampshire SO30 3JB

United Kingdom

Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)

London, London, City of NW1 2PG

United Kingdom

Warneford Hospital ( Site 8007)

Oxford, Oxfordshire OX3 7JX

United Kingdom

Remind UK ( Site 8003)

Bath, Somerset BA1 3NG

United Kingdom

Re:Cognition Health - Birmingham ( Site 8002)

Birmingham, B16 8LT

United Kingdom