Do you or someone you know have mild cognitive impairment or mild dementia due to Alzheimer’s disease?
Learn about a clinical trial for early Alzheimer’s disease.
About the trial
Researchers are testing an investigational drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied called MK-2214 in people who have mild cognitive impairment or mild dementiaDementiaMental decline; loss of memory, communication and decision-making that can interfere with everyday activities due to Alzheimer’s disease.
The goals of this trial are to:
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Test the safety of MK-2214
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See how well MK-2214 may work to help slow the progression of Alzheimer’s disease
About the investigational drug
The investigational drug, MK-2214, is experimentalExperimental StudyA type of test or study to learn more about the effects and safety of a medicine or treatment. It has not been approved to treat or prevent mild cognitive impairment or mild dementia due to Alzheimer’s disease or other conditions. The purpose of this study is to see if MK-2214, an investigational tau-targeting monoclonal antibodyMonoclonal antibodyA lab-made antibody (protein) that acts by finding and attaching to specific cells, may help slow progression of Alzheimer’s disease in participantsParticipantPerson; people in a clinical trial. with early Alzheimer’s.
If you qualify and decide to join this trial, you will be randomly (by chance) assigned to get either the investigational drug, MK-2214, or a placeboPlaceboA placebo looks like the study medicine but has no study medicine/treatment in it. Using a placebo helps researchers better understand the effects of the study medicine/treatment.. A placebo looks like the investigational drug but has no active ingredients. Using a placebo helps researchers better understand the actual effects of an investigational drug.
The investigational drug and placebo are both given through a needle in a vein. This is called intravenous (IV)Intravenous (IV)Medicine or fluid given through a needle or flexible tube into a vein infusion. You will get IV infusions of your assigned trial drug every 4 weeks for about 2 years.
NATIONAL TRIAL REFERENCE NUMBER
NCT07033494
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Discuss with your doctor
Your doctor is your best resource for deciding if a trial is right for you, but your personal support team can also help you along the way.
How to qualify
You may be able to join this clinical trial if you:
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Are 50 to 85 years of age
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Have mild cognitive impairment or mild dementia due to Alzheimer’s disease
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Have a person (trial partner) who can go with you to specific trial visits and help complete some of the trial requirements
If you are currently taking medication for Alzheimer’s disease, you may still be able to participate.
The trial doctor will give you more information and talk with you about other requirements to join this trial as well as possible benefitsClinical benefitA measurement of a positive effect of a treatment or medicine. This effect could make a difference in how people feel, function, or survive; A health change that researchers measure to find out if the study treatment helps the study participants, risksRiskChance (likelihood) for an event, reaction or health problem to happen, and side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment.
Will I receive the investigational drug if I take part?
People who participate in this trial will be randomly (by chance) assigned to get either the investigational drug, MK-2214, or the placebo. You will have a 3 in 5 chance of getting the investigational drug, MK-2214, and a 2 in 5 chance of getting the placebo. You, the trial doctor and team, and your trial partner will not know whether you are getting the investigational drug or the placebo. In case of a health emergency, they can find out.
What happens during the trial?
Before joining this trial, you will have a screeningScreeningTesting (checking, looking) for a condition or disease; a process conducted by researchers to see if a person meets the requirements to participate in a clinical study visit to find out if you are eligibleEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria to join. If you can and want to join the trial, you will read and sign an Informed Consent Form (ICF). The ICF gives you details about the trial, including the medical tests you can expect and the risks and possible benefits of participating.
If you qualify and decide to take part, you and your trial partner will be in this trial for about 2½ years, and you will have about 29 monthly visits.
This study has up to 3 parts:
Screening
(about 3 months)
You will have medical tests to see if you qualify for the trial and visit the trial site 1 or more times. Screening lasts up to 12 weeks, or about 3 months.
Treatment
(up to 2 years)
You and your trial partner will visit the trial site about once a month to get your assigned trial drug through IV infusion.
You may also have additional tests and assessments during these visits which your trial doctor will discuss with you.
Follow-up period
(about 3 months)
You will have a safety follow-up visit 3 months after the last IV infusion. You may be offered the opportunity to participate in an extension trial, where all participants get the investigational drug.
About early Alzheimer's disease
Alzheimer’s is a brain disease caused by a buildup of sticky clumps called amyloid plaques and tau tangles. In people with Alzheimer’s disease, these changes damage the brain and eventually lead to dementiaDementiaMental decline; loss of memory, communication and decision-making that can interfere with everyday activities. The investigational drug, MK-2214, is being studied to see if it may slow the spreading of tau tangles and the progression of Alzheimer’s disease.
The most common early symptoms of Alzheimer’s disease include memory loss, new problems speaking or writing, difficulty learning or solving problems, and changes in mood and personality.
Early Alzheimer’s disease includes people with:
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Mild cognitive impairment (MCI) due to Alzheimer’s disease. This is when people have more memory or thinking problems than other people their age but can still live normally.
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Mild dementia due to Alzheimer’s disease. This is when people’s memory or thinking problems become noticeable and start to affect their daily life.
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 team member for more information.
About the trial
This trial is being done to test an investigational drug, MK-2214, in people who have mild cognitive impairment or mild dementia due to Alzheimer’s disease to see if it may help slow the progression of Alzheimer’s disease.
Deciding to join a clinical trial is something only you, those close to you, and your care team can decide together. If there is anything about the clinical trial that you don’t understand, ask the trial doctor.
Before you agree to participate, the trial team will review all aspects of the clinical trial with you and your trial partner. If you decide to take part, you will be given a document called an Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) 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 ingredients. Researchers use a placebo to see if the investigational drug works better or is safer than taking nothing or taking a different drug.
In this clinical trial, you have a 2 in 5 (40%) chance of getting a placebo.
Privacy, withdrawing, costs, and permission
The trial team 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 investigational drug.
No, the trial drugs and all trial-related tests are provided at no cost.
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 tries to answer questions about how medicines work in the people who take them. Researchers run clinical trials to test whether an investigational drug is safe and effective. These clinical trials 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 clinical trials. These rules are put in place to make sure clinical trials follow strict scientific and ethical guidelines.
Before a clinical trial can begin, a review board or ethics committee must review the clinical trial. In the US, this group is called an Institutional Review Board (IRB)Institutional Review Board (IRB)(In US): A team of people who review studies to protect the rights and welfare of study participants; A group formally designated and responsible for reviewing study proposals, monitoring studies involving people and protecting the rights and welfare of study participants. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion 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 drug 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.
Understanding research studies is important when making a decision about joining one. To see more Frequently Asked Questions, click on the link below.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Discuss with your doctor or care team
Print this page with details about the clinical trial or email it to your doctor to discuss the clinical trial during your next visit.
Get help talking with your doctor or support team
Contact our Clinical Trial Information Center
To learn more, call 1-888-577-8839.
NATIONAL TRIAL REFERENCE NUMBER
NCT07033494
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, it is important to learn as much as you can about:
- The investigational drug that is being studied
- What the risks and 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 things to think about and questions to ask
Reference:
1. Gibney M. Merck & Co. assembles an Alzheimer’s comeback with a next-gen precision focus. PharmaVoice. Published August 1, 2025. Accessed August 6, 2025. https://www.pharmavoice.com/news/merck-alzheimers-disease-tau-comeback-precision-medicine/756517/