Not recruiting

Study on the Safety and Effectiveness of MK-1942 for Patients with Mild to Moderate Alzheimer's Disease

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's Disease, a condition that affects memory and thinking skills. The study is testing a new treatment called MK-1942, which is taken as a capsule. The purpose of the study is to evaluate the safety and effectiveness of MK-1942 when used alongside existing treatments for people with mild to moderate Alzheimer's Disease.

Participants in the study will receive either the MK-1942 capsule or a placebo, which looks like the treatment but does not contain the active substance. The study will last for 12 weeks, during which participants will take the capsules twice a day. Researchers will monitor changes in memory and thinking skills using a test called the Alzheimer's Disease Assessment Scale, as well as any side effects experienced by participants.

The study aims to provide more information about how well MK-1942 works and how safe it is for people with Alzheimer's Disease. This research could help improve treatment options for those living with this condition. Participants will continue their usual Alzheimer's medications during the study, ensuring that any changes observed are due to the new treatment being tested.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as having mild to moderate Alzheimer's disease dementia and a mini-mental state examination score between 12 and 22.
You will need to have a study partner who can provide information about your daily activities and overall health. This partner should be someone who spends enough time with you to understand your behavior and cognitive performance.
Step 2
Medication administration
You will be randomly assigned to receive either the study medication, MK-1942, or a placebo. The medication will be in the form of a hard capsule taken orally.
The dosage of MK-1942 will be either 5 mg or 15 mg, taken twice a day. The duration of this medication administration will be 12 weeks.
Step 3
Regular assessments
Throughout the 12-week period, you will undergo regular assessments to monitor the effects of the medication. These assessments will include evaluations of your cognitive abilities using the Alzheimer's Disease Assessment Scale and other related measures.
Your safety and the tolerability of the medication will also be closely monitored. This involves tracking any adverse events or side effects you may experience.
Step 4
Final evaluation
At the end of the 12-week period, a final evaluation will be conducted. This will include a comprehensive assessment of any changes in your cognitive abilities and daily living activities.
The results of these assessments will help determine the efficacy and safety of the study medication compared to the placebo.

Who can join the trial?

5 criteria

The patient must have mild to moderate AD dementia. This is determined by specific criteria from a recognized association.
The patient must have a Mini-Mental State Examination (MMSE) score between 12 and 22. This is a test that helps measure cognitive function.
The patient must be using acetylcholinesterase inhibitors (AChEI) for managing AD dementia. These are medications that help with symptoms of dementia. The dose must have been stable for at least 3 months before starting the study and should remain constant during the study.
The patient must have a designated study partner. This is someone who knows the patient well, spends enough time with them, and can provide information about their daily activities, behavior, and health for the study.
The study is open to both male and female participants.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **AD dementia** (a type of memory and thinking problem) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.
Patients who do not meet the safety and tolerability requirements for the study cannot participate.

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Verified sites

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Verified
Milan, Italy
Fondazione IRCCS San Gerardo Dei Tintori
Verified
Monza, Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain

Trial locations

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Investigated drugs

MK-1942 is a medication being studied to see if it can help people with mild to moderate Alzheimer's disease. Alzheimer's disease is a condition that affects the brain and can cause problems with memory and thinking. This medication is being tested to find out if it can improve these symptoms when used alongside other treatments. The study is also looking at whether the medication is safe and if people can tolerate it well. Participants in the trial are taking this medication to see if it can help them think more clearly and remember things better.

Mk-1942

What is already known about the treatment

MK-1942 – MK-1942 is a medication currently being studied in clinical trials for its potential use in treating mild to moderate Alzheimer's disease dementia. It is administered orally in tablet form, taken twice daily at doses of 5 mg and 15 mg. The main goal of the ongoing research is to determine how well MK-1942 improves cognitive function, as measured by a specific test called the ADAS-Cog11, and to assess its safety and tolerability. MK-1942 works by targeting specific pathways in the brain that are believed to be involved in the progression of Alzheimer's disease, although the exact molecular mechanism is still under investigation. It is classified as an investigational drug, meaning it is not yet approved for general medical use and is only available to participants in clinical trials.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The progression of Alzheimer's Disease varies among individuals, but it generally follows a slow and continuous decline in cognitive and functional abilities.