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 San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Lawren Vandevrede

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
  • Inglewood Clinical ( Site 1062) accepting new patients
    Los Angeles California 90056 United States

Lead Scientist at UCSF

  • Lawren Vandevrede
    Dr. Lawren VandeVrede is a neurologist who cares for patients with dementia and other memory disorders. VandeVrede's research focuses on improving scientific understanding of neurodegenerative disorders (conditions in which nerve cells progressively deteriorate or die) and developing treatments for them.

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
Contact us about this trial