RecruitingPHASE2INTERVENTIONAL

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

This study is investigating a new treatment, MK-2214, for people who are in the early stages of Alzheimer's disease. Alzheimer's is a condition that affects memory, communication, and decision-making over time. Researchers want to discover if MK-2214 can slow down changes in the brain that are linked to the disease, specifically the build-up of a protein called tau. They're comparing MK-2214 to a dummy treatment (placebo) to understand its effects better. The study will also carefully check for any side effects and how well people tolerate the new medication. This research aims to find out if MK-2214 could offer a new way to help manage early Alzheimer's.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

340

Start

16 Jul 2025

Estimated completion

30 Apr 2029

Early Alzheimer's Disease

What is this study about?

This study is focused on a new medication called MK-2214, which aims to help people with early Alzheimer's disease. Alzheimer's is a condition that gradually affects a person's memory, thinking, and daily abilities. In Alzheimer's, a protein called tau can build up in the brain and damage brain cells, which scientists believe contributes to the symptoms. Researchers want to find out if MK-2214 can help slow down this build-up of tau.

To do this, some participants will receive MK-2214, while others will receive a 'placebo'. A placebo looks exactly like the study medication but contains no active ingredients. This helps researchers compare the effects of the new medication fairly. By doing this, they can effectively see if any improvements or changes are truly due to MK-2214 or if they might happen naturally or due to other factors.

The main goals are to learn if MK-2214 slows down the spread of tau in the brain and to thoroughly check if the medication is safe to use and if people can take it without too much discomfort. This research is important because it could lead to new treatments that help manage early Alzheimer's and improve the lives of those affected.

Key takeaways

This study is testing a new medication, MK-2214, for early Alzheimer's disease.
Researchers want to see if MK-2214 can slow down changes in the brain.
It will also check how safe MK-2214 is and if people can tolerate it.
Participation involves regular clinic visits, assessments, and brain scans.
A 'study partner' will need to be involved to help with parts of the research.
You might receive the new drug or a dummy treatment (placebo).

Who may be eligible?

To be considered for this study, you would need to be between 50 and 85 years old and have been diagnosed with either mild memory problems or mild dementia that doctors believe is due to Alzheimer's disease. You would also need someone, like a family member or close friend, who can act as your 'study partner' and help during the study.

There are also some conditions that would mean you couldn't take part. For example, if you've had a stroke, certain brain conditions not related to Alzheimer's, or serious medical illnesses recently. Also, if you have a history of seizures, certain heart or liver problems, or if you can't have brain scans like MRI, then this study might not be suitable for you.

The study also wouldn't be right for you if you live in a nursing home or care facility where you need constant medical care. If you are already taking medication for Alzheimer's, you might still be able to join, but your current medication dose would need to have been stable for at least three months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 85 years old?
Do you have a diagnosis of mild memory problems or mild dementia due to Alzheimer's?
Do you have a family member or close friend who can be your study partner?
Have you *not* had a stroke or other serious brain conditions?
Are you able to have brain scans like MRI or PET?
Do you *not* have other serious or uncontrolled health problems?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, you would have assessments, which might include memory tests, physical check-ups, and blood tests. You would also need to undergo brain scans, such as MRI or PET scans, which help researchers see changes in the brain. You would be given the study medication (either MK-2214 or the placebo) to take as directed.

Your designated study partner would also be involved, helping with some of the assessments and providing information to the research team. The study team will explain the full schedule and what each visit involves. The total duration of your participation would be fully explained before you decide to join, and it's important to commit to the full study period for the research to be effective.

Potential risks and benefits

While we hope this study will help us learn more about treating early Alzheimer's, there's no guarantee that participating will directly benefit your health. You might receive the new medication, or you might receive a placebo, which has no active drug. There's a chance you could experience side effects from the medication, and these will be carefully explained to you. All medical procedures carry some risks, and these will be detailed by the study team. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (78)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Irvine Clinical Research ( Site 1041)
Verified postcode
Irvine, United States· Recruiting
Healthy Brain Clinic ( Site 1005)
Verified postcode
Long Beach, United States· Recruiting
Inglewood Clinical ( Site 1062)
Verified postcode
Los Angeles, United States· Recruiting
Anderson Clinical Research ( Site 1024)
Verified postcode
Redlands, United States· Recruiting
UCSF Memory and Aging Center ( Site 1031)
Verified postcode
San Francisco, United States· Recruiting
Syrentis Clinical Research ( Site 1001)
Verified postcode
Santa Ana, United States· Recruiting
Yale University, Alzheimer's Disease Research Unit ( Site 1059)
Verified postcode
New Haven, United States· Recruiting
JEM Research Institute ( Site 1046)
Verified postcode
Atlantis, United States· Recruiting
Neuropsychiatric Research Center of Southwest Florida ( Site 1003)
Verified postcode
Fort Myers, United States· Recruiting
Indago Research & Health Center, Inc ( Site 1044)
Verified postcode
Hialeah, United States· Recruiting
K2 Medical Research ( Site 1047)
Verified postcode
Maitland, United States· Recruiting
ClinCloud LLC ( Site 1039)
Verified postcode
Melbourne, United States· Recruiting

Common questions

What is Alzheimer’s disease?

Alzheimer’s disease is a condition that affects the brain, causing problems with memory, thinking, and daily activities over time.

What is MK-2214?

MK-2214 is a new medication being tested to see if it can slow down certain changes in the brains of people with early Alzheimer’s disease.

What is a placebo?

A placebo is a dummy treatment that looks like the real medication but doesn't have any active ingredients. It helps researchers compare the effects of the new drug.

Will I know if I'm getting the drug or the placebo?

No, during the study you won't know if you're getting MK-2214 or the placebo. This helps make the study as fair and accurate as possible.

What is a 'study partner'?

A study partner is often a family member or close friend who helps by attending some appointments and providing information to the research team about your daily life and memory.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.