Do you or someone you know have Alzheimer’s disease dementia?
You or your loved one may be eligible for a clinical trial while continuing your current Alzheimer's medicine.
About the Trial
Researchers want to learn about an investigational drug in people with mild to moderate Alzheimer’s disease dementia. The clinical trial is evaluating the safety of an investigational drug, MK-1167, and how well it may work when people take it with their current Alzheimer’s disease dementia medicine. MK-1167 is experimental. It has not been approved to treat or prevent Alzheimer’s disease dementia or other conditions.
About the investigational drug
If you qualify and decide to join this trial, you will be randomly assigned by a computer to take either an investigational drug, MK-1167, or a placebo. The placebo looks like the investigational drug but contains no active ingredients.
The investigational drug and the placebo are both capsules. You will take the assigned capsule once each day by mouth during the 24-week trial treatment period.
NATIONAL TRIAL REFERENCE NUMBER
NCT06721156
When you talk with your doctor or clinical team member, please have the national trial reference number available.
Discuss with your doctor or care team
Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
How to qualify
You may qualify to take part in this clinical trial if you are 55 to 90 years old and:
- Have mild to moderate Alzheimer’s disease dementia
- Are taking a type of medicine for Alzheimer’s disease dementia called a cholinergic medicine, such as donepezil, galantamine, or rivastigmine. The trial doctor can tell you if you are unsure.
- Have a trial partner/caregiver who can go with you to all trial visits and:
- Knows you well
- Is in regular contact with you
- Can answer questions and surveys
There are more requirements to take part in this trial, which the trial doctor will discuss with you.
If you qualify and decide to participate:
- You will get the investigational drug or the placebo and all trial-related medical tests at no cost to you.
- Your Alzheimer’s disease dementia symptoms and overall health will be checked and tracked by a trial doctor.
- You may help researchers learn more about Alzheimer’s disease dementia and the investigational drug.
Participation in the clinical trial is voluntary, and you are free to leave at any time. Your privacy will be maintained throughout the trial.
Will I receive the investigational drug if I take part?
People who participate in this trial will be randomly assigned (by chance) to receive either the investigational drug or the placebo.
You will have a 5-in-7 chance of being assigned to get the investigational drug and a 2-in-7 chance of receiving the placebo. Participants, the trial doctor, and the trial team will not know which group each participant is placed in.
You will continue to take your current Alzheimer’s disease dementia treatment throughout the clinical trial.
What will happen during the clinical trial?
Taking part in the trial lasts about 10 months with at least 9 visits to the trial site. There are also at least 2 virtual visits with a member of the trial staff.
The trial has 3 parts: Screening, Treatment, and Follow-up.
Screening
Up to 3 months
You will have 1 to 2 site visits for medical tests to see if you qualify for the trial.
Treatment
About 6 months
You will have about 7 site visits and 2 virtual visits. You will receive the investigational drug or the placebo.
Follow-up
About 1 month
You will have 1 visit to the trial site.
Clinical trial tests
During the clinical trial, you will have different tests to evaluate your health. Not all tests are done at every visit.
At the start of the trial, you will need to do brain imaging if you have not done so in the past year.
You will also be asked to answer questions or make drawings to measure how well you think, reason, remember, and make judgments. Your trial partner/caregiver will also answer questions and surveys.
Other tests include, but are not limited to:
- Physical exams
- Blood tests
- Urine samples
- Vital signs (heart rate and blood pressure)
- Electrocardiogram (ECG), a test that shows how well your heart is working
About Alzheimer’s disease dementia
Alzheimer’s is a brain disease caused by a buildup of sticky clumps called plaques and tangles. In people with Alzheimer’s, these changes damage the brain and eventually lead to dementia.
The most common early symptoms of Alzheimer’s disease include:
- Memory loss
- New problems speaking or writing
- Difficulty learning or problem-solving
- Changes in mood and personality
When these symptoms begin to interfere with the ability to perform everyday tasks, people are said to have Alzheimer’s disease dementia. Alzheimer’s disease is progressive, which means it gets worse over time.
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
Frequently Asked Questions
About the MK1167-008 Alzheimer’s Trial
The MK1167-008 Alzheimer’s Trial is evaluating the safety of an investigational drug, MK-1167, and how well it may work when people take it with their current Alzheimer’s disease dementia medicine.
There are requirements that must be met in order to take part in this study. The trial doctor or staff will discuss them with you. Before you agree to participate, the trial team will review all aspects of the clinical trial with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the clinical trial’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo looks like the investigational drug but does not contain any active medication.
You will have a 5-in-7 chance of being assigned to get the investigational drug and a 2-in-7 chance of receiving the placebo. Participants, the trial doctor, and the trial team will not know which group each participant is placed in.
You will continue to take your current Alzheimer’s disease dementia treatment throughout the clinical trial.
Privacy, Withdrawing, Costs, and Permission
The trial staff respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Yes, your participation in the clinical trial is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the trial team before doing so. You will be asked to return to the trial site at least once to complete a final visit and return any unused study drug.
The study drug and all trial-related tests are provided at no cost. You may be reimbursed for trial-related travel expenses.
No, your doctor does not have to give permission for you to participate. However, either you or the trial doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Clinical Trials
A clinical trial, also known as a research study, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational study medicine is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the United States, this group is called an IRB or an Institutional Review Board. An IRB is made up of doctors, scientists, and other member of the community.
Only people who meet all eligibility criteria for a clinical trial may take part. The trial team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the trial team determine whether you may be eligible.
An investigational drug is a medicine that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational drug must be tested in clinical trials to see if it is safe and effective for treating the target disease in certain groups of people.
If you are eligible and choose to participate, the trial staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/
What can you do next?
If you are interested in taking part in this clinical trial, take the next steps to see if you are eligible.
Discuss with your doctor or care team
Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.
Get help talking with your doctor or care team
Contact our Trial Information Center
To learn more, call 1-888-577-8839.
NATIONAL TRIAL REFERENCE NUMBER
NCT06721156
When you talk with your doctor or clinical team member, please have the national trial reference number available.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational drug that is being studied
- What the possible risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
Reference:
1. Alzheimer’s Association. 2024 Alzheimer’s disease facts and figures. Alzheimer’s Dement. 2024:20(5);3708-3821. doi:10.1002/alz.13809