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RecruitingPhase 2

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

Asset

MK-2214

Listed sites

79

Recruiting sites

79

Enrollment

340

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required•Uncontrolled bleeding disorder excluded

Primary endpoints

•Tau PET Standardized Uptake Value Ratio (SUVr)•Number of Participants Who Experience One or More Adverse Events (AEs)•Number of Participants Who Discontinue Study Intervention Due to an AE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Registry2024-519190-19-00EU CT
Org study ID2214-004
RegistryjRCT2031250299Japan Registry of Clinical Trial (jRCT)
Secondary IDMK-2214-004MSD
NCT IDNCT07033494
RegistryU1111-1314-8296UTN

Timeline

Milestones

Study first posted2025-06-24actual
Study start2025-07-16actual
Last update posted2026-07-06actual
Primary completion2029-04-30estimated
Study completion2029-04-30estimated

Assets

Drug assets

MK-2214

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
4
Tau biomarkers
4
Safety / tolerability / PK
1
Other (unclassified)
1

Global cognition

4 endpoints
Secondary/protocol endpoint

Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score

Time frame:Baseline, up to approximately 23 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score

Time frame:Baseline, up to approximately 23 months

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score

Time frame:Baseline, up to approximately 23 months

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score

Time frame:Baseline, up to approximately 23 months

ADAS-Cog

change from baseline, improvement

Tau biomarkers

4 endpoints
Primary/protocol endpoint

Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)

Time frame:Baseline, up to approximately 23 months

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV

Time frame:Baseline, up to approximately 23 months

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Composite Tau PET SUVr

Time frame:Baseline, up to approximately 23 months

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI

Time frame:Baseline, up to approximately 23 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants Who Experience One or More Adverse Events (AEs)

Time frame:Up to approximately 26 months

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame:Up to approximately 23 months

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.