CompletedPhase 1

A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)

A Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease

Lead sponsor

Merck Sharp & Dohme LLC

Asset

MK-2214

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•mild-to-moderate AD•MMSE ≥12

Primary endpoints

•Number of Participants Who Experience At Least One Adverse Event (AE)•Number of Participants Who Discontinue Study Treatment Due to an AE•Serum AUC of MK-2214 from Time 0

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

Org study ID2214-002

Secondary IDMK-2214-002MSD

NCT IDNCT05466422

Timeline

Milestones

Study first posted2022-07-20actual

Study start2022-09-20actual

Primary completion2025-07-03actual

Study completion2025-07-03actual

Last update posted2025-08-27actual

Assets

Drug assets

MK-2214

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participant is in overall good health based on medical history and laboratory safety tests

•BMI between 18.5 and 35 kg/m^2

Part 1 (MCI and Mild to Moderate AD) Only:

•History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening

•Have an Mini-Mental State Examination (MMSE) >12 at the prestudy visit

•Modified Hachinski Ischemic Score (MHIS) score <4 at the prestudy visit

Exclusion criteria

•Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), has reported suicidal ideation with intent, with or without a plan or method

•History of unstable or poorly controlled endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases

•History of clinically significant active neurological disease (except for AD or MCI for participants in Part 1)

•History of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy

•History of cancer (malignancy)

•History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food

•Positive test(s) for Hepatitis B Surface Antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)

•Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy visit

•Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture

•Currently receiving or has received aducanumab or another anti-amyloid therapy within the last 6 months

•Has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year

•Has received any non-live vaccine starting from 14 days prior to first study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. Exception: COVID-19 and influenza vaccines may be administered

•Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses

Endpoints (9)

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

Safety / tolerability / PK

Fluid / digital biomarkers

Other (unclassified)

Fluid / digital biomarkers

3 endpoints

Primary/protocol endpoint

Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85 (C85d)

Time frame:Day 85

concentration, descriptive

Primary/protocol endpoint

Percentage change from baseline to Day 29 in free phospho-tau in CSF

Time frame:Baseline and Day 29 pre-dose

percent change from baseline, improvement

Primary/protocol endpoint

Percentage change from baseline to Day 85 in free phospho-tau in CSF

Time frame:Baseline and Day 85

percent change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Number of Participants Who Experience At Least One Adverse Event (AE)

Time frame:Up to approximately 297 days

event count, event

Primary/protocol endpoint

Serum Area Under the Concentration-Time Curve of MK-2214 from Time 0 to 28 Hours (AUC0-28) After First and Third Dose

Time frame:At designated time points (up to 85 days)

concentration, descriptive

Primary/protocol endpoint

Serum Maximum Concentration (Cmax) of MK-2214 After First and Third Dose

Time frame:At designated time points (up to 85 days)

concentration, descriptive

Primary/protocol endpoint

Serum Time to Maximum Concentration (Tmax) of MK-2214 After First and Third Dose

Time frame:At designated time points (up to 85 days)

time to event, event

Primary/protocol endpoint

Serum Apparent Terminal Half-Life (t1/2) of MK-2214 After First and Third Dose

Time frame:At designated time points (up to 85 days)

concentration, descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame:Up to approximately 57 days

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.