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

Recruiting
50 - 80 years of age
Both
Phase 1

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Overview

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). Optional healthy older participants (Part 2) may receive MK-2214 at dose levels determined by criteria met in Part 1.

Eligibility

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

Study details

Alzheimer Disease

NCT05466422

Merck Sharp & Dohme LLC

25 January 2024

Step 1 Get in touch with the nearest study center
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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