MK-2214 for people with early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled trial gives participants either MK-2214 or a matching placebo and follows them over time to measure changes in brain tau and clinical safety. The primary goal is to see if MK-2214 slows tau accumulation in the brain compared with placebo while monitoring side effects and tolerability. Eligible participants include people with mild cognitive impairment or mild dementia due to Alzheimer's who have a study partner, and those on approved symptomatic AD therapies must be on a stable dose. Outcome measures will focus on brain measures of tau and standard safety labs, exams, and tolerability assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

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

Where it's running

• Irvine Clinical Research ( Site 1041)
  Irvine, California, United States Recruiting
• Healthy Brain Clinic ( Site 1005)
  Long Beach, California, United States Recruiting
• Inglewood Clinical ( Site 1062)
  Los Angeles, California, United States Recruiting
• Anderson Clinical Research ( Site 1024)
  Redlands, California, United States Recruiting
• UCSF Memory and Aging Center ( Site 1031)
  San Francisco, California, United States Recruiting
• Syrentis Clinical Research ( Site 1001)
  Santa Ana, California, United States Recruiting

+30 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.