RecruitingPhase 2NCT07033494

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

A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Sponsor

Merck Sharp & Dohme LLC

Enrollment

340 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Early Alzheimer's Disease

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests an investigational drug called MK-2214 in people with early-stage Alzheimer's disease — to see if it is safe and effective at slowing memory decline. **You may be eligible if...** - You have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease - You have a designated study partner (like a family member or close friend) who can attend visits with you - If you are on an approved Alzheimer's treatment, your dose must have been stable for at least 3 months **You may NOT be eligible if...** - You have a known history of certain neurological or psychiatric conditions - You do not have a study partner available - Your cognitive decline is caused by something other than Alzheimer's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMK-2214

IV infusion

DRUGPlacebo

IV infusion

Locations(71)

Irvine Clinical Research ( Site 1041)

Irvine, California, United States

Healthy Brain Clinic ( Site 1005)

Long Beach, California, United States

Inglewood Clinical ( Site 1062)

Los Angeles, California, United States

Anderson Clinical Research ( Site 1024)

Redlands, California, United States

UCSF Memory and Aging Center ( Site 1031)

San Francisco, California, United States

Syrentis Clinical Research ( Site 1001)

Santa Ana, California, United States

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

New Haven, Connecticut, United States

JEM Research Institute ( Site 1046)

Atlantis, Florida, United States

Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

Fort Myers, Florida, United States

Indago Research & Health Center, Inc ( Site 1044)

Hialeah, Florida, United States

K2 Medical Research ( Site 1047)

Maitland, Florida, United States

ClinCloud LLC ( Site 1039)

Melbourne, Florida, United States

Aqualane Clinical Research ( Site 1035)

Naples, Florida, United States

Suncoast Clinical Research ( Site 1007)

New Port Richey, Florida, United States

Renstar Medical Research ( Site 1012)

Ocala, Florida, United States

Charter Research - Orlando ( Site 1051)

Orlando, Florida, United States

Axiom Brain Health ( Site 1029)

Tampa, Florida, United States

K2 Medical Research ( Site 1020)

Tampa, Florida, United States

Charter Research - Lady Lake ( Site 1019)

The Villages, Florida, United States

Conquest Research LLC ( Site 1053)

Winter Park, Florida, United States

CenExel iResearch, LLC ( Site 1015)

Decatur, Georgia, United States

Alexian Brothers Medical Center-Neurosciences ( Site 1017)

Elk Grove Village, Illinois, United States

Boston Center for Memory ( Site 1008)

Newton, Massachusetts, United States

Clinical Research Professionals ( Site 1004)

Chesterfield, Missouri, United States

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

Ridgewood, New Jersey, United States

The Cognitive and Research Center of NJ ( Site 1057)

Springfield, New Jersey, United States

CenExel- AMRI ( Site 1018)

Toms River, New Jersey, United States

Alzheimer Disease Research Center (ADRC) ( Site 1000)

Albany, New York, United States

Mid Hudson Medical Research ( Site 1050)

New Windsor, New York, United States

Basil Clinical ( Site 1065)

Queens, New York, United States

Insight Clinical Trials ( Site 1011)

Independence, Ohio, United States

Neuro-Behavioral Clinical Research ( Site 1028)

North Canton, Ohio, United States

Flourish Research ( Site 1048)

Plymouth Meeting, Pennsylvania, United States

Gadolin Research ( Site 1032)

Beaumont, Texas, United States

Horizon Clinical Research Center - Houston ( Site 1026)

Cypress, Texas, United States

Organizacion Medica de Investigacion ( Site 0401)

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

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

Caba, Argentina

Southern Neurology ( Site 0306)

Kogarah, New South Wales, Australia

KARA Institute for Neurological Diseases ( Site 0302)

Macquarie Park, New South Wales, Australia

Austin Health ( Site 0300)

Ivanhoe, Victoria, Australia

HammondCare ( Site 0301)

Malvern, Victoria, Australia

Cliniques universitaires Saint-Luc ( Site 3001)

Brussels, Bruxelles-Capitale, Region de, Belgium

UZ Leuven ( Site 3000)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge Campus Kennedylaan ( Site 3002)

Kortrijk, West-Vlaanderen, Belgium

National Center for Geriatrics and Gerontology ( Site 9002)

Ōbu, Aichi-ken, Japan

Chibaken Saiseikai Narashino Hospital ( Site 9000)

Narashino, Chiba, Japan

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)

Kawasaki, Kanagawa, Japan

Mie University Hospital ( Site 9011)

Tsu, Mie-ken, Japan

Katayama Medical Clinic ( Site 9005)

Kurashiki, Okayama-ken, Japan

National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)

Kanzaki-gun, Saga-ken, Japan

Tokyo Medical University Hospital ( Site 9003)

Shinjuku, Tokyo, Japan

Inage Neurology and Memory Clinic ( Site 9001)

Chiba, Japan

Kyushu University Hospital ( Site 9010)

Fukuoka, Japan

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

Okayama, Japan

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

's-Hertogenbosch, North Brabant, Netherlands

Brain Research Center. ( Site 5000)

Amsterdam, North Holland, Netherlands

Brain Research Center Zwolle ( Site 5002)

Zwolle, Overijssel, Netherlands

Hanyang University Hospital ( Site 0200)

Seoul, South Korea

Samsung Medical Center ( Site 0202)

Seoul, South Korea

Ewha Womans University Seoul Hospital ( Site 0201)

Seoul, South Korea

Hospital Universitari Mutua Terrassa ( Site 6004)

Terrassa, Barcelona, Spain

Fundació ACE ( Site 6003)

Barcelona, Catalonia, Spain

Hospital del Mar ( Site 6001)

Barcelona, Spain

Hospital Clinic i Provincial ( Site 6002)

Barcelona, Spain

Scottish Brain Sciences Aberdeen ( Site 8001)

Aberdeen, Aberdeen City, United Kingdom

Scottish Brain Sciences ( Site 8000)

Edinburgh, Edinburgh, City of, United Kingdom

Moorgreen Hospital ( Site 8004)

Southampton, Hampshire, United Kingdom

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

London, London, City of, United Kingdom

Warneford Hospital ( Site 8007)

Oxford, Oxfordshire, United Kingdom

Remind UK ( Site 8003)

Bath, Somerset, United Kingdom

Re:Cognition Health - Birmingham ( Site 8002)

Birmingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07033494

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