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

Merck Sharp & Dohme (MSD)

Status and phase

Not yet enrolling

Phase 2

Conditions

Early Alzheimer's Disease

Treatments

Biological: MK-2214

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07033494

2214-004

MK-2214-004 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

340 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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