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

RECRUITINGPHASE2

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

NCT07033494•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+4 more criteria

Locations (70)

Inglewood Clinical ( Site 1062)

Inglewood, California, United States

Irvine Clinical Research ( Site 1041)

Irvine, California, United States

Healthy Brain Clinic ( Site 1005)

Long Beach, 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

Key Dates

Start Date

July 16, 2025

Primary Completion Date

April 30, 2029

Completion Date

April 30, 2029

Last Updated

March 13, 2026

Enrollment

340

ESTIMATED participants

Conditions

Early Alzheimer's Disease

Interventions

MK-2214

BIOLOGICAL

Placebo

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease

NCT04599764

Transcranial Direct Current StimulationFunctional Magnetic Resonance Imaging+1 more

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ACTIVE_NOT_RECRUITINGPHASE3

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

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Early Alzheimer's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease