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

Last updated: November 21, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

Dementia

Memory Loss

Mild Cognitive Impairment

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: 48
Treatment Group(s): 2
Primary Treatment: MK-2214
Phase: 1
Study Start date:
September 20, 2022
Estimated Completion Date:
July 02, 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

  • 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

  • CenExel iResearch, LLC ( Site 0002)

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Atlanta ( Site 0002)

    Decatur, Georgia 30030
    United States

    Active - Recruiting

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

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research ( Site 0016)

    North Canton, Ohio 44720
    United States

    Site Not Available

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