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

NCT ID: NCT07033494

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2029-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Early Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MK-2214

Participants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the study.

Group Type EXPERIMENTAL

MK-2214

Intervention Type BIOLOGICAL

IV infusion

Placebo

Participants will receive a placebo via IV infusion q4w during the study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion

Interventions

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MK-2214

IV infusion

Intervention Type BIOLOGICAL

Placebo

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Inglewood Clinical ( Site 1062)

Inglewood, California, United States

Site Status RECRUITING

Irvine Clinical Research ( Site 1041)

Irvine, California, United States

Site Status RECRUITING

Healthy Brain Clinic ( Site 1005)

Long Beach, California, United States

Site Status RECRUITING

Anderson Clinical Research ( Site 1024)

Redlands, California, United States

Site Status RECRUITING

UCSF Memory and Aging Center ( Site 1031)

San Francisco, California, United States

Site Status RECRUITING

Syrentis Clinical Research ( Site 1001)

Santa Ana, California, United States

Site Status RECRUITING

JEM Research Institute ( Site 1046)

Atlantis, Florida, United States

Site Status RECRUITING

Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

Fort Myers, Florida, United States

Site Status RECRUITING

K2 Medical Research ( Site 1047)

Maitland, Florida, United States

Site Status RECRUITING

ClinCloud LLC ( Site 1039)

Melbourne, Florida, United States

Site Status RECRUITING

Aqualane Clinical Research ( Site 1035)

Naples, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research ( Site 1007)

New Port Richey, Florida, United States

Site Status RECRUITING

Renstar Medical Research ( Site 1012)

Ocala, Florida, United States

Site Status RECRUITING

Charter Research - Orlando ( Site 1051)

Orlando, Florida, United States

Site Status RECRUITING

K2 Medical Research Tampa LLC ( Site 1020)

Tampa, Florida, United States

Site Status RECRUITING

Axiom Brain Health ( Site 1029)

Tampa, Florida, United States

Site Status RECRUITING

Charter Research - Lady Lake ( Site 1019)

The Villages, Florida, United States

Site Status RECRUITING

Conquest Research LLC ( Site 1053)

Winter Park, Florida, United States

Site Status RECRUITING

CenExel iResearch, LLC ( Site 1015)

Decatur, Georgia, United States

Site Status RECRUITING

Alexian Brothers Medical Center-Neurosciences ( Site 1017)

Elk Grove Village, Illinois, United States

Site Status RECRUITING

Boston Center for Memory ( Site 1008)

Newton, Massachusetts, United States

Site Status RECRUITING

Clinical Research Professionals ( Site 1004)

Chesterfield, Missouri, United States

Site Status RECRUITING

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

Ridgewood, New Jersey, United States

Site Status RECRUITING

The Cognitive and Research Center of NJ ( Site 1057)

Springfield, New Jersey, United States

Site Status RECRUITING

CenExel- AMRI ( Site 1018)

Toms River, New Jersey, United States

Site Status RECRUITING

Alzheimer Disease Research Center (ADRC) ( Site 1000)

Albany, New York, United States

Site Status RECRUITING

Basil Clinical ( Site 1065)

Queens, New York, United States

Site Status RECRUITING

Insight Clinical Trials ( Site 1011)

Independence, Ohio, United States

Site Status RECRUITING

Neuro-Behavioral Clinical Research ( Site 1028)

North Canton, Ohio, United States

Site Status RECRUITING

Flourish Research ( Site 1048)

Plymouth Meeting, Pennsylvania, United States

Site Status RECRUITING

Gadolin Research ( Site 1032)

Beaumont, Texas, United States

Site Status RECRUITING

Horizon Clinical Research Center - Houston ( Site 1026)

Cypress, Texas, United States

Site Status RECRUITING

National Center for Geriatrics and Gerontology ( Site 9002)

Ōbu, Aichi-ken, Japan

Site Status RECRUITING

Katayama Medical Clinic ( Site 9005)

Kurashiki, Okayama-ken, Japan

Site Status RECRUITING

Tokyo Medical University Hospital ( Site 9003)

Shinjuku, Tokyo, Japan

Site Status RECRUITING

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

Okayama, , Japan

Site Status RECRUITING

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

's-Hertogenbosch, North Brabant, Netherlands

Site Status RECRUITING

Brain Research Center. ( Site 5000)

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Brain Research Center Zwolle ( Site 5002)

Zwolle, Overijssel, Netherlands

Site Status RECRUITING

Ewha Womans University Seoul Hospital ( Site 0201)

Seoul, , South Korea

Site Status RECRUITING

Scottish Brain Sciences ( Site 8000)

Edinburgh, Edinburgh, City of, United Kingdom

Site Status RECRUITING

Moorgreen Hospital ( Site 8004)

Southampton, Hampshire, United Kingdom

Site Status RECRUITING

Remind UK ( Site 8003)

Bath, Somerset, United Kingdom

Site Status RECRUITING

Re:Cognition Health - Birmingham ( Site 8002)

Birmingham, , United Kingdom

Site Status RECRUITING

Countries

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United States Japan Netherlands South Korea United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-2214-004

Identifier Type: OTHER

Identifier Source: secondary_id

2024-519190-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1314-8296

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031250299

Identifier Type: REGISTRY

Identifier Source: secondary_id

2214-004

Identifier Type: -

Identifier Source: org_study_id