A Clinical Study of MK-2214 in People with Early Alzheimer’s Disease

  • Study Director: 
  • Sponsor: Merck Sharp & Dohme LLC
  • Status: Recruiting
  • Official Study Title: Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of MK-2214 in Participants with Early Alzheimer’s Disease
  • ClinicalTrials.gov Identifier: NCT07033494
  • Conditions Studied: Early Alzheimer’s Disease
  • Intervention: MK-2214 (Biological – IV infusion every 4 weeks)
  • Phase: Phase 2
  • Duration of Participation: Up to 23–26 months

Purpose of the Study

The purpose of this Phase 2 clinical study is to evaluate the efficacy and safety of MK-2214, a potential treatment for early Alzheimer’s disease. Researchers aim to determine whether MK-2214 can slow the spread of tau protein in the brain, compared to a placebo. Tau is a protein that accumulates in Alzheimer’s disease and damages brain cells, contributing to cognitive decline and the progression of the disease.

The study also seeks to assess the overall safety and tolerability of MK-2214 in participants and monitor its impact on cognitive function, daily activities, and other measures of Alzheimer’s progression.

Eligibility

Inclusion Criteria
  • Diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.
  • Must have a designated study partner to assist with study requirements.
  • If receiving symptomatic AD therapy, dosing regimen must be stable for at least 3 months prior to screening.
Exclusion Criteria
  • History of stroke or cerebrovascular disease.
  • Diagnosis of a central nervous system disease other than Alzheimer’s.
  • History of seizures or epilepsy within 5 years.
  • Structural brain disease or other major medical illnesses.
  • Uncontrolled immunological disease or history of malignancy within 5 years.
  • Unable to undergo required imaging (e.g., MRI, PET).
  • Residing in a nursing home requiring continuous medical care.

What to Expect

Testing: Participants will undergo neurological and physical examinations, MRIs, PET scans, lumbar punctures, cognitive testing, neuropsychiatric assessments, blood and urine specimen collection, EKGs, and regular telephone check-ins.

The Frequency of Visits: Every 4 weeks

Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.

Costs: Study procedures are provided at no cost. Parking is validated at UCSF public garages for all study visits.

Contact Information

Coordinator: [email protected], 415.353.3585
Clinical Trials Nurse: Whitney Walker, MS, CNS, RN – [email protected], 415.353.7532