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

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

Recruiting
50-85 years
All
Phase 2

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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

Eligibility

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

Study details
    Early Alzheimer's Disease

NCT07033494

Merck Sharp & Dohme LLC

1 November 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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