RECRUITING

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

Description

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

Conditions

Early Alzheimer's Disease
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Related Conditions:

Early Alzheimer's Disease

Study Overview

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Study Details

Study overview

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

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

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

Condition
Early Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Atlantis

JEM Research Institute ( Site 1046), Atlantis, Florida, United States, 33462

Tampa

Axiom Brain Health ( Site 1029), Tampa, Florida, United States, 33609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

50 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-04-30