Testing MK-2214 in people with early Alzheimer's disease

Trial details

Who runs it

Merck Sharp & Dohme LLC

Trial code

NCT07033494EU 2024-519190-19-00

Record updated

20 October 2026

Original description

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.Read full original descriptionShow less

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

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

Inclusion: 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: Has major medical illness or unstable medical condition within 3 months before screening; Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study; 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 a bleeding disorder that is not under adequate control; Has a history of malignancy occurring within 5 years of screening; Has liver disease; Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality; Has a risk factor for corrected QT interval (QTc) prolongation; The main exclusion criteria include but are not limited to the following:; 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.

ClinicalTrials.gov NCT07033494 · EU CTIS 2024-519190-19-00