Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at UCSF
Dates
study started
study 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 5391959 California 5332921 94158 United States
  • Irvine Clinical Research ( Site 1041) accepting new patients
    Irvine 5359777 California 5332921 92614 United States
  • Syrentis Clinical Research ( Site 1001) accepting new patients
    Santa Ana 5392900 California 5332921 92705 United States
  • Inglewood Clinical ( Site 1062) accepting new patients
    Inglewood 5359488 California 5332921 90301 United States
  • Healthy Brain Clinic ( Site 1005) accepting new patients
    Long Beach 5367929 California 5332921 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