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

NCT ID: NCT05466422

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2025-07-03

Brief 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).

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-2214

Participants will receive MK-2214 administered in escalating doses as an intravenous (IV) infusion on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

MK-2214

Intervention Type: BIOLOGICAL

MK-2214 in escalating doses as an IV infusion on Days 1, 29, and 57

Placebo

Participants will receive placebo as an IV infusion on Days 1, 29, and 57.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo as an IV infusion on Days 1, 29, and 57

Interventions

MK-2214

MK-2214 in escalating doses as an IV infusion on Days 1, 29, and 57

Intervention Type: BIOLOGICAL

Placebo

Placebo as an IV infusion on Days 1, 29, and 57

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Countries

United States

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-2214-002

Identifier Type: OTHER

Identifier Source: secondary_id

2214-002

Identifier Type: -

Identifier Source: org_study_id