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

Last updated: August 26, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Dementia

Mild Cognitive Impairment

Memory Loss

Treatment

MK-2214

Placebo

Clinical Study ID

NCT05466422
2214-002
MK-2214-002
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of MK-2214 in adults with mild cognitive impairment (MCI) or mild-to-moderate Alzheimer's Disease (AD). The primary hypothesis (Part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at Day 85 of MK-2214 in cerebrospinal fluid is >0.3 nanomolar (nM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • 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 progressionfor 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

Exclusion Criteria:

  • Based on clinical interview and Columbia-Suicide Severity Rating Scale (C-SSRS), hasreported 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 genitourinaryabnormalities or diseases

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

  • History of clinically significant active autoimmune disease requiring ongoingsystemic immunosuppressant therapy

  • History of cancer (malignancy)

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

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

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

  • Has a contraindication to lumbar dural puncture, such as coagulopathy, concomitantanticoagulation beyond low dose aspirin, thrombocytopenia, or other factors thatcould preclude safe lumbar puncture

  • Currently receiving or has received aducanumab or another anti-amyloid therapywithin 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 studyintervention or is scheduled to receive any non-live vaccine through 14 daysfollowing the final dose of study intervention. Exception: COVID-19 and influenzavaccines may be administered

  • Is receiving systemic immunosuppression, including corticosteroids exceedingphysiologic replacement doses

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: MK-2214
Phase: 1
Study Start date:
September 20, 2022
Estimated Completion Date:
July 03, 2025

Connect with a study center

  • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)

    Glendale, California 91206
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC ( Site 0009)

    Long Beach, California 90806
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC ( Site 0009)

    Los Alamitos, California 90720
    United States

    Site Not Available

  • NRC Research Institute ( Site 0015)

    Orange, California 92868
    United States

    Site Not Available

  • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007)

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC ( Site 0009)

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • NRC Research Institute ( Site 0015)

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach ( Site 0001)

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Research Centers of America ( Hollywood ) ( Site 0004)

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Charter Research - Lady Lake ( Site 0011)

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • K2 Medical Research ( Site 0005)

    Maitland, Florida 32751
    United States

    Site Not Available

  • Charter Research - Winter Park ( Site 0012)

    Orlando, Florida 32803
    United States

    Site Not Available

  • Progressive Medical Research-Alzheimer's Team ( Site 0013)

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Charter Research - Lady Lake ( Site 0011)

    The Villages, Florida 32162
    United States

    Site Not Available

  • Charter Research - Winter Park ( Site 0012)

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach ( Site 0001)

    Hallandale 4157898, Florida 4155751 33009
    United States

    Site Not Available

  • Research Centers of America ( Hollywood ) ( Site 0004)

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • K2 Medical Research ( Site 0005)

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Charter Research - Winter Park ( Site 0012)

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Progressive Medical Research-Alzheimer's Team ( Site 0013)

    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Charter Research - Lady Lake ( Site 0011)

    The Villages 4175179, Florida 4155751 32162
    United States

    Site Not Available

  • CenExel iResearch, LLC ( Site 0002)

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta ( Site 0002)

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • CenExel iResearch, LLC ( Site 0002)

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003)

    Princeton 5102922, New Jersey 5101760 08540
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research ( Site 0016)

    North Canton, Ohio 44720
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research ( Site 0016)

    North Canton 5164706, Ohio 5165418 44720
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.