Status:

RECRUITING

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Early Alzheimer's Disease

Eligibility:

All Genders

50-85 years

Phase:

PHASE2

Brief 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 memo...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2029

Estimated Enrollment :

340 Patients enrolled

Trial Details

Trial ID

NCT07033494

Start Date

July 16 2025

End Date

April 30 2029

Last Update

March 13 2026

Active Locations (70)

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Page 1 of 18 (70 locations)

1

Inglewood Clinical ( Site 1062)

Inglewood, California, United States, 90301

2

Irvine Clinical Research ( Site 1041)

Irvine, California, United States, 92614

3

Healthy Brain Clinic ( Site 1005)

Long Beach, California, United States, 90804

4

Anderson Clinical Research ( Site 1024)

Redlands, California, United States, 92374