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MK-2214 for people with early Alzheimer's disease

A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT07033494

This trial will test whether the drug MK-2214 can slow the spread of tau protein in the brains of people with mild cognitive impairment or mild dementia from Alzheimer's disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment340 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations75 sites (Irvine, California and 74 other locations)
Trial IDNCT07033494 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo-controlled trial gives participants either MK-2214 or a matching placebo and follows them over time to measure changes in brain tau and clinical safety. The primary goal is to see if MK-2214 slows tau accumulation in the brain compared with placebo while monitoring side effects and tolerability. Eligible participants include people with mild cognitive impairment or mild dementia due to Alzheimer's who have a study partner, and those on approved symptomatic AD therapies must be on a stable dose. Outcome measures will focus on brain measures of tau and standard safety labs, exams, and tolerability assessments.

Who should consider this trial

Good fit: People with mild cognitive impairment or mild dementia due to Alzheimer's disease who have a designated study partner and stable dosing on any approved symptomatic AD therapy are ideal candidates.

Not a fit: People with a history of stroke or other major cerebrovascular or central nervous system disease, recent seizures, structural brain disease, or unstable major medical illness are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, MK-2214 could slow Alzheimer's-related tau buildup and potentially delay worsening of thinking and day-to-day function.

How similar studies have performed: Tau-targeting treatments are an active area of research but so far have produced mixed, mostly early-stage results, so this approach is promising but not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

* Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
* Has a designated study partner who can fulfill the requirements of this study
* If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening

Exclusion Criteria:

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

* Has a known history of stroke or cerebrovascular disease
* Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
* Has structural brain disease
* Has a history of seizures or epilepsy within 5 years before screening
* Has any other major central nervous system trauma, or infections that affect brain function
* Has major medical illness or unstable medical condition within 3 months before screening
* Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
* Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
* Has a bleeding disorder that is not under adequate control
* Has a history of malignancy occurring within 5 years of screening
* Has a risk factor for corrected QT interval (QTc) prolongation
* Has liver disease
* Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

Where this trial is running

Irvine, California and 74 other locations

+25 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Early Alzheimer's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.