A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
a study on Alzheimer's Disease
Summary
- Eligibility
- for people ages 50-85 (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
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
Official Title
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
Keywords
Early Alzheimer's Disease, Alzheimer Disease
Eligibility
You can join if…
Open to people ages 50-85
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
You CAN'T join if...
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
Locations
- UCSF Memory and Aging Center ( Site 1031)
accepting new patients
San Francisco California 94158 United States - Irvine Clinical Research ( Site 1041)
accepting new patients
Irvine California 92614 United States - Syrentis Clinical Research ( Site 1001)
accepting new patients
Santa Ana California 92705 United States - Inglewood Clinical ( Site 1062)
accepting new patients
Inglewood California 90301 United States - Healthy Brain Clinic ( Site 1005)
accepting new patients
Long Beach California 90804 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Merck Sharp & Dohme LLC
- Links
- Merck Clinical Trials Information
- ID
- NCT07033494
- Phase
- Phase 2 Alzheimer's Disease Research Study
- Study Type
- Interventional
- Participants
- Expecting 340 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.