A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy and Safety of MK-1167 as Adjunctive Therapy in Participants with Mild to Moderate Alzheimer’s Disease Dementia
This research study is looking into a new medicine called MK-1167 for individuals who have early to medium stages of Alzheimer's disease. It's a 'Phase 2' study, meaning scientists are checking if this new medicine is effective and safe. Participants will be randomly given either the new medicine or a 'dummy' pill (placebo) over 24 weeks. This helps researchers understand if any changes are truly due to the medicine. The main things they'll be checking are how the medicine affects memory and thinking abilities, and if participants experience any side effects. They'll also look at how it impacts daily activities and overall well-being. This kind of study is crucial for developing new treatments that could help people living with Alzheimer's disease.
At a glance
What is this study about?
Imagine the brain like a complex computer. In Alzheimer's disease, parts of this computer start to malfunction, affecting memory, thinking, and daily tasks. Scientists are always working to find new ways to help slow down these changes or improve how the brain works. This particular study is trying out a new medicine, called MK-1167, to see if it can be helpful for people who have mild to moderate Alzheimer's disease.
This is a 'Phase 2' study. Think of it like a second-stage test in developing a new car. The first stage might be testing the engine, and now in Phase 2, they're seeing how the whole car drives on a test track. For medicine, this means they're looking closely at whether the medicine actually works (its 'efficacy') and if it's safe to use.
During the study, some people will receive the new medicine, and others will get what's called a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients – it's a dummy pill. This is a common and important way that researchers can compare the two groups to tell if any improvements or side effects are truly from the new medicine or if they might be happening for other reasons.
Key takeaways
- This study is testing a new medicine (MK-1167) for mild to moderate Alzheimer's disease.
- It aims to see if the medicine improves thinking and memory, and if it's safe.
- Participants will receive either the new medicine or a dummy pill (placebo).
- The study lasts about 24 weeks and involves regular clinic visits.
- Your health and memory skills will be closely monitored throughout the study.
Who may be eligible?
Generally, to take part in this study, you would need to be an adult over 18 years old. Both men and women are welcome to participate. The study is specifically looking for people who have been diagnosed with mild to moderate Alzheimer's disease.
Being eligible often means meeting certain health criteria that the researchers have set to make sure the study is safe and that the results they get are clear and accurate. For example, they'll want to make sure your diagnosis of Alzheimer's fits a specific picture, and that you don't have other health conditions that might interfere with the study medicine or the assessments.
It's important to remember that not everyone with Alzheimer's disease will be able to join every study. Doctors and the study team will carefully review your medical history and current health to see if this particular study is a good fit for you.
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 18 years old or older?
- Have you been diagnosed with mild to moderate Alzheimer's disease?
- Are you able to attend regular clinic appointments for about 6 months?
- Are you generally in good health apart from your Alzheimer's diagnosis?
What does participation involve?
If you decide to take part, you would receive either the new study medicine (MK-1167) or a dummy pill (placebo) for 24 weeks, which is about six months. You wouldn't know which one you're getting, and neither would your study doctor, to keep the results fair. During this time, you would have regular visits to the clinic. At these visits, doctors and nurses would check your memory and thinking skills using special tests, and they would also check your overall health and ask about any new symptoms or side effects you might be experiencing. These checks are done at different points, like at 12 weeks and then again at 24 weeks. The total duration of active treatment and follow-up would be around 24 weeks.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is MK-1167?
MK-1167 is the name of the new medicine being tested in this study for Alzheimer's disease.
What does 'mild to moderate Alzheimer's disease' mean?
This refers to the early and middle stages of Alzheimer's disease, where symptoms are noticeable but may not be as severe as in later stages.
Will I definitely get the new medicine?
No, because it's a 'randomised' study, you'll have an equal chance of getting either the new medicine (MK-1167) or a dummy pill (placebo).
What does a 'dummy pill' do?
A dummy pill, called a placebo, looks like the real medicine but doesn't contain any active ingredients. It helps researchers compare the effects of the active medicine.
How long does the study last?
Participants will take the study treatment for about 24 weeks (roughly 6 months), with regular check-ups during this time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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