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Study of MK-2214 to slow disease progression in people with early Alzheimer's disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Early Alzheimer's Disease, a condition that affects memory and thinking abilities. The research evaluates a new medication called MK-2214, which will be compared with a placebo. The purpose is to determine if MK-2214 can slow down the spread of harmful proteins in the brain that are associated with Alzheimer's disease.

During the study, participants will receive either MK-2214 through intravenous infusion (delivery of medication through a vein) or a placebo. Additionally, participants will undergo PET scans (a type of medical imaging) using a substance called Florquinitau F18, which helps doctors see certain changes in the brain related to Alzheimer's disease.

The study will monitor how the disease progresses over time by measuring changes in brain imaging and performing various tests that assess memory, thinking abilities, and daily living activities. The research team will also track any side effects that participants may experience during the treatment period, which may last up to 100 weeks.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and screening
A medical evaluation will confirm if you have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease.
You will need to have a designated study partner who can assist throughout the study.
If you are currently taking Alzheimer's Disease medication, you must have been on a stable dose for at least 3 months before screening.
Step 2
Brain imaging procedure
You will undergo a PET scan (a special type of brain imaging) to measure tau protein levels in your brain.
During the PET scan, you will receive an injection of Florquinitau F18, a substance that helps visualize tau protein in the brain.
This imaging will serve as your baseline measurement for comparison throughout the study.
Step 3
Treatment assignment
You will be randomly assigned to receive either MK-2214 or a placebo (an inactive substance).
Neither you nor your doctor will know which treatment you are receiving.
The medication will be given through an intravenous injection or infusion (directly into your vein).
Step 4
Monitoring and assessments
Regular evaluations will track changes in your cognitive abilities using various tests.
Your daily living activities will be assessed using specific rating scales.
Additional PET scans will be performed to measure changes in tau protein levels.
Any side effects or adverse reactions will be monitored and documented.
Step 5
Study completion
The study will continue from August 2025 to September 2029.
Final assessments will include cognitive testing and brain imaging.
Your participation will help evaluate if MK-2214 can slow the progression of Alzheimer's Disease.

Who can join the trial?

6 criteria

Must have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease - this means early memory and thinking problems that are noticeable but don't severely impact daily life
Must have a study partner who can regularly participate in the study - this is usually a family member or close friend who spends time with the patient regularly and can help monitor changes
If currently taking approved medications for Alzheimer's Disease symptoms, the dose must have remained unchanged for at least 3 months before starting the screening process
Must be an adult (both men and women can participate)
Must be able to undergo PET scanning - a type of medical imaging that uses a special dye to look at brain changes
Must be able to understand and follow study procedures and provide informed consent

Who cannot join the trial?

15 criteria

History of serious allergic reactions or severe drug reactions
Active or recent (within 6 months) cancer diagnosis requiring treatment
Significant heart conditions including unstable heart disease, recent heart attack, or severe heart failure
Severe liver disease or abnormal liver function tests
Severe kidney disease or significantly reduced kidney function
Current participation in other clinical trials or use of investigational drugs within 30 days before this study
History of stroke or brain hemorrhage within the past year
Uncontrolled high blood pressure
Severe psychiatric conditions that could interfere with study participation
Regular use of medications that could interact with the study drug
Alcohol or substance abuse within the past year
Conditions that could affect brain imaging results (such as metal implants)
Inability to undergo brain imaging procedures
Pregnancy, breastfeeding, or planning to become pregnant during the study
Any condition that, in the opinion of study doctors, would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

MK-2214 MK-2214 is an investigational medication being studied for the treatment of early Alzheimer's Disease. The medication is being tested to see if it can slow down the spread of tau protein in the brain, which is one of the markers of Alzheimer's Disease progression. The medication's effectiveness will be measured using special brain imaging called PET scans that can track tau protein buildup in the brain.

Florquinitau (18F)

What is already known about the treatment

MK-2214 – An investigational drug currently being studied in Phase 2 clinical trials for the treatment of Early Alzheimer's Disease. This experimental medication is being evaluated for its potential ability to slow down the progression of tau protein spreading in the brain, which is one of the key pathological features of Alzheimer's Disease. The drug's effectiveness is being measured through specialized brain imaging techniques called tau PET scans, which can track changes in tau protein accumulation. As a therapeutic candidate in the neurodegenerative disease category, MK-2214 is undergoing rigorous testing to establish both its safety profile and its potential efficacy in modifying the course of early-stage Alzheimer's Disease.

Investigated diseases

Alzheimer's Disease - A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins slowly and typically first affects parts of the brain that control memory, with symptoms beginning with difficulty remembering recent events or conversations. Over time, symptoms worsen and include problems with thinking, reasoning, making decisions, and changes in behavior and personality. The disease causes brain cells to degenerate and die, leading to a continuous decline in mental function. As the disease advances, people experience growing confusion and disorientation, especially in relation to time and place. The condition is characterized by the accumulation of abnormal protein deposits in the brain called amyloid plaques and tau tangles.