A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
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
Merck Sharp & Dohme LLC
340 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
Summary
Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it
Eligibility
Inclusion Criteria3
- 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 Criteria14
- 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
Interventions
IV infusion
IV infusion
Locations(70)
View Full Details on ClinicalTrials.gov
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NCT07033494