|

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

RECRUITINGPhase 2Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 2
SponsorMerck Sharp & Dohme LLC
Started2025-07-16
Est. completion2029-04-30
Eligibility
Age50 Years – 85 Years
Healthy vol.Accepted
Locations35 sites

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

Age: 50 Years – 85 YearsHealthy volunteers accepted
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

Conditions2

Alzheimer's DiseaseEarly Alzheimer's Disease

Locations35 sites

Inglewood Clinical ( Site 1062)
Inglewood, California, 90301
Study Coordinator949-265-1612
Irvine Clinical Research ( Site 1041)
Irvine, California, 92614
Study Coordinator949-753-1663
Healthy Brain Clinic ( Site 1005)
Long Beach, California, 90804
Study Coordinator562-606-5999
Anderson Clinical Research ( Site 1024)
Redlands, California, 92374
Study Coordinator909-792-9007
UCSF Memory and Aging Center ( Site 1031)
San Francisco, California, 94158
Study Coordinator415-353-3585

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.