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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MK-2214 in people with early Alzheimer's disease. Researchers will see if it slows the spread of tau, a protein that builds up and harms brain cells, compared with a placebo (a treatment with no study drug). They will also check its safety and how well people handle it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild thinking or memory problems, or mild dementia, due to Alzheimer's disease.
  • Have a study partner who can meet the study's requirements.
  • If taking an approved drug for Alzheimer's symptoms, have been on a steady dose for at least 3 months before screening.

Who can't join

  • Have a history of stroke or disease of the brain's blood vessels; another important brain or nerve disease; lasting thinking problems from another condition; or problems with the brain's structure.
  • Had seizures or epilepsy within 5 years before screening, or have had another major brain or spinal cord injury or an infection affecting brain function.
  • Had a major illness or unstable health condition within 3 months before screening, or have a severe, sudden, or long-term medical or mental health condition or an abnormal lab result.
  • Have an immune system disease that is not well controlled or needs biologic drugs or drugs that weaken the immune system during the study.
  • Have a bleeding disorder that is not well controlled, liver disease, or a history of cancer within 5 years before screening.
  • Have a risk factor for a heart rhythm problem called QTc prolongation.
  • Cannot or will not have CT, PET, or MRI scans, which take pictures inside the body.
  • Live in a nursing home or assisted care facility and need ongoing, direct medical care and nursing supervision.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (36)

CA

CT

FL

GA

IL

MA

MO

NC

NJ

NY

OH

PA

TX