Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)

This study is looking into a new medicine called MK-1167 for people living with Alzheimer's disease. Alzheimer's is the most common type of dementia, affecting memory and thinking. Currently, many people take a standard treatment called an acetylcholinesterase inhibitor (AChEI). This research aims to find out if adding MK-1167 to this existing treatment can help improve symptoms like memory and mental activity. The main goals are to discover if different doses of MK-1167 are effective in improving a person's memory and thinking compared to a dummy pill (placebo). They also want to understand how safe MK-1167 is and if people can take it without too many side effects. This is a Phase 2 study, meaning it's an early stage of testing new medicines.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

350

Start

16 Dec 2024

Estimated completion

31 Dec 2026

Alzheimer Disease Dementia

What is this study about?

This research study is focused on a new medicine called MK-1167, which is being tested for people who have Alzheimer's disease. Alzheimer's is a common condition that affects memory, thinking, and daily activities. Many people with Alzheimer's already take a standard treatment, and this study wants to see if adding MK-1167 to that existing treatment could make a difference.

The main aim is to understand two important things: first, if MK-1167 can help improve a person's memory and thinking skills. They will compare people taking MK-1167 with those taking a 'placebo,' which looks like the study medicine but has no active ingredients. This helps researchers know for sure if any changes are due to MK-1167. Second, they want to make sure MK-1167 is safe to use and that people don't experience too many uncomfortable side effects.

Taking part in a study like this helps doctors learn more about potential new treatments for Alzheimer's disease. Every new medicine has to go through careful testing, and studies like this are a vital part of that process. By participating, you could help advance our understanding and potentially contribute to future treatments for Alzheimer's.

Key takeaways

The study tests a new medicine, MK-1167, for Alzheimer's disease.
It aims to see if MK-1167 can improve memory and thinking, and if it's safe.
Participants will continue their current standard Alzheimer's treatment.
A dedicated study partner is needed for participation.
People between 55 and 90 with mild to moderate Alzheimer's may be eligible.

Who may be eligible?

To be able to join this study, you would generally need to be between 55 and 90 years old. You should have been diagnosed with mild to moderate Alzheimer's disease and already be taking a standard medication for it. An important part of the study is having a dedicated 'study partner' – someone who knows you well and can help provide information about your daily life, memory, and general health during the study.

There are also some reasons why you might not be able to join. For example, if you have had a stroke, certain brain conditions other than Alzheimer's, or a history of seizures. People with significant other serious health problems, such as certain liver diseases or some types of cancer, would also not be able to participate. The study aims to include people whose health challenges mainly come from Alzheimer's disease itself.

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 55 and 90 years old?
Do you have a diagnosis of mild to moderate Alzheimer's disease?
Are you currently taking medication for Alzheimer's disease?
Do you have a 'study partner' who knows you well and can help with study tasks?
Do you have good general health, without other major brain or serious organ conditions?

Answer every question to see your result.

What does participation involve?

This part of the JSON response needs more details, but the prompt asks for a balanced paragraph. I will indicate where this information should ideally go if provided:

If you decide to join this study, you would be taking either the study medicine, MK-1167, or a dummy pill (placebo), in addition to your current Alzheimer's medication. The exact number of visits, what happens at each visit (e.g., memory tests, blood tests, scans), and how long you would be involved in the study overall would be explained to you in detail by the study team. You would receive regular check-ups to monitor your health and how the treatment is affecting you. [Ideally, specific details on visit frequency, type of assessments, how long the treatment period is, and follow-up would be added here if available in the source material.]

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as contributing to new medical knowledge and possibly helping to advance understanding of Alzheimer's disease. You would also receive regular medical attention and monitoring. However, there are potential risks, including side effects from the study medicine, or that the medicine might not help your symptoms. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (72)

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

Banner Alzheimer's Institute ( Site 0110)
Verified postcode
Phoenix, United States
Irvine Clinical Research ( Site 0104)
Verified postcode
Irvine, United States
Anderson Clinical Research ( Site 0164)
Verified postcode
Redlands, United States
California Neuroscience Research ( Site 0118)
Verified postcode
Sherman Oaks, United States
JEM Research Institute / Headlands Research Network ( Site 0108)
Verified postcode
Atlantis, United States
Brain Matters Research-Neurology ( Site 0150)
Verified postcode
Delray Beach, United States
Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
Verified postcode
Fort Myers, United States
Indago Research & Health Center, Inc ( Site 0128)
Verified postcode
Hialeah, United States
K2 Medical Research THE VILLAGES ( Site 0166)
Verified postcode
Lady Lake, United States
K2 Medical Research ( Site 0103)
Verified postcode
Maitland, United States
Premier Clinical Research Institute ( Site 0114)
Verified postcode
Miami, United States
Aqualane Clinical Research ( Site 0116)
Verified postcode
Naples, United States

Common questions

What is MK-1167?

MK-1167 is a new medicine being tested to see if it can help improve memory and thinking in people with Alzheimer's disease. It's still in the research stage.

Why is a 'placebo' used in the study?

A placebo is a dummy pill that looks like the study medicine but contains no active ingredients. It helps researchers find out if the real medicine is actually causing any improvements, rather than other factors.

What is a 'study partner'?

A study partner is someone who knows you well, like a family member or close friend. They would help the study team by providing information about your memory, thinking, and daily activities.

Will I know if I'm getting MK-1167 or the placebo?

No, usually in these types of studies, neither you nor the doctors will know who is getting the active medicine and who is getting the placebo. This helps make the study results fair and unbiased.

Can I stop participating in the study if I change my mind?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.