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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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).

Key facts

Study ID

NCT05466422

Run by

Merck Sharp & Dohme LLC

People needed

34

Starts

2022-09-20

Expected to finish

2025-07-03

Last updated by the study team

2025-08-27

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0007) — Glendale, California, United States
• Collaborative Neuroscience Research, LLC ( Site 0009) — Los Alamitos, California, United States
• NRC Research Institute ( Site 0015) — Orange, California, United States
• Velocity Clinical Research, Hallandale Beach ( Site 0001) — Hallandale, Florida, United States
• Research Centers of America ( Hollywood ) ( Site 0004) — Hollywood, Florida, United States
• K2 Medical Research ( Site 0005) — Maitland, Florida, United States
• Charter Research - Winter Park ( Site 0012) — Orlando, Florida, United States
• Progressive Medical Research-Alzheimer's Team ( Site 0013) — Port Orange, Florida, United States
• Charter Research - Lady Lake ( Site 0011) — The Villages, Florida, United States
• CenExel iResearch, LLC ( Site 0002) — Decatur, Georgia, United States
• Global Medical Institutes LLC; Princeton Medical Institute ( Site 0003) — Princeton, New Jersey, United States
• Neuro-Behavioral Clinical Research ( Site 0016) — North Canton, Ohio, United States

Full record on ClinicalTrials.gov

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