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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)

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Alzheimer Disease

Interventions: MK-2214, Placebo

Countries: United States

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-2214 in adults with mild cognitive impairment or mild-to-moderate Alzheimer's Disease. 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

Eligibility overview

Sex: ALL

Age: 50 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Participant is in overall good health based on medical history and laboratory safety tests
* Body mass index between 18.5 and 35 kg/m\^2

Part 1 (Mild Cognitive Impairment \[MCI\] and Mild-to-Moderate Alzheimer's Disease \[AD\]) Only:

* History of cognitive and functional decline with gradual onset and slow progression for at least one year before Screening
* Mini-Mental State Examination (MMSE) score \>12 at the prestudy visit
* Modified Hachinski Ischemic Score (MHIS) \<4 at the prestudy visit

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* 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: coronavirus disease of 2019 (COVID-19) and influenza vaccines may be administered
* Is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses

Locations (12)

Glendale, California, United States
Los Alamitos, California, United States
Orange, California, United States
Hallandale, Florida, United States
Hollywood, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Port Orange, Florida, United States
The Villages, Florida, United States
Decatur, Georgia, United States
Princeton, New Jersey, United States
North Canton, Ohio, United States