MK-2214 for Early Alzheimer's Disease

This study is looking at MK-2214, a treatment given through an IV (intravenous infusion), for people with early Alzheimer's disease (AD). AD is a condition that affects memory and thinking. Researchers want to see if MK-2214 can slow down the spread of a protein called tau in the brain, which is linked to AD. You would receive either MK-2214 or a placebo (a substance that looks like the treatment but has no active medicine). The study will also check how safe MK-2214 is and if people can tolerate it. They plan to enroll about 340 participants between 50 and 85 years old who have mild cognitive impairment (MCI) or mild dementia due to AD. You would also need a study partner.

Study design
This is an interventional study planning to enroll 340 participants. It compares the effects of MK-2214 to a placebo.
What's involved
The study measures changes in tau protein in the brain for up to about 23 months. Safety will be monitored for up to approximately 26 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to approximately 26 months after starting the study.

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NCT07033494

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Recruiting
PHASE2Ages 50–85InterventionalTreatment
Merck Sharp & Dohme LLC
~340 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:MK-2214Placebo

At a glance

Recruiting sites
80 of 80 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)
Measured over Baseline, up to approximately 23 months
+2 more outcomes measured
Early Alzheimer's Disease
80 sites across 46 states
Florida13
California6
New Jersey3
New York3
Ontario3
Japan3
South Korea3
Ohio2
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Eligibility criteria

Inclusion

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

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
  • Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)Baseline, up to approximately 23 months

    Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported.

  • Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 26 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.

  • Number of Participants Who Discontinue Study Intervention Due to an AEUp to approximately 23 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.