A study testing MK-1167 added to current treatment in patients with mild to moderate Alzheimer’s disease dementia

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What is this study about?

This study is looking at Alzheimer’s disease dementia, which is a condition that affects memory, thinking, and the ability to perform daily activities. The study will test a medicine called MK-1167, which will be given as capsules taken by mouth. Some people in the study will receive MK-1167 while others will receive placebo. All people in the study will continue taking their current medicine from a group called acetylcholinesterase inhibitors, which are medicines already being used to manage Alzheimer’s disease dementia. The study is designed to find out if MK-1167 works well when added to the usual treatment and to check if it is safe.

The study will last for 24 weeks, which is about six months. During this time, people in the study will be checked to see how their thinking abilities, daily activities, and overall condition change. The study will measure changes in memory and thinking using specific tests, and will look at how well people can perform everyday tasks. Doctors will also watch for any unwanted effects that might happen while people are taking the study medicine.

This is a type of study where neither the people taking part nor the doctors know who is getting the real medicine and who is getting placebo until the study is finished. This helps make sure the results are accurate and fair. The study will compare how people do on MK-1167 plus their usual medicine compared to people on placebo plus their usual medicine.

1 Beginning of treatment period

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will receive either MK-1167 or placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

You will continue taking your current acetylcholinesterase inhibitor medication throughout the study. Acetylcholinesterase inhibitors are medications commonly used to manage symptoms of Alzheimer’s disease.

The study medication will be provided in capsule form and taken by mouth.

2 Treatment administration and assessments during first 12 weeks

You will take the assigned study medication as directed while continuing your regular acetylcholinesterase inhibitor therapy.

During this period, your cognitive function will be monitored using the Alzheimer’s Disease Assessment Scale, which is a test that evaluates memory, language, and thinking abilities.

Your daily living activities will be assessed using the Alzheimer’s Disease Cooperative Study Activities of Daily Living scale, which evaluates your ability to perform everyday tasks.

A clinical assessment will be conducted to evaluate any overall changes in your condition using the Clinical Global Impression of Change scale.

Any side effects or health changes you experience will be recorded throughout this period.

3 Week 12 assessment

At week 12, a comprehensive evaluation will be performed.

Your cognitive abilities will be assessed again using the Alzheimer’s Disease Assessment Scale to measure any changes from the beginning of the study.

Your ability to perform daily activities will be evaluated to determine any changes from baseline.

An overall clinical assessment will be conducted to evaluate changes in your condition.

4 Continuation of treatment from week 12 to week 24

You will continue taking the assigned study medication along with your regular acetylcholinesterase inhibitor therapy.

Monitoring of your health status and any side effects will continue throughout this period.

5 Week 24 final assessment

At week 24, the final comprehensive evaluation will be performed.

Your cognitive function will be assessed using the Alzheimer’s Disease Assessment Scale to measure changes from the beginning of the study. This is the primary measure of the study’s effectiveness.

Your daily living activities will be evaluated again to determine any changes from baseline.

An overall clinical assessment will be conducted to evaluate changes in your condition.

A final review of any side effects or health changes experienced during the study will be completed.

6 End of study participation

After completing the week 24 assessment, your participation in the study will be concluded.

The total duration of your participation in the treatment phase of the study will be approximately 24 weeks.

Who Can Join the Study?

You must have mild to moderate Alzheimer’s Disease dementia, which means you are in Stage 4 or Stage 5 of the disease based on specific medical guidelines
Your score on a Mini-Mental State Examination must be between 12 and 24. This is a test that measures memory, attention, and thinking abilities
You must already be taking acetylcholinesterase inhibitors, which are medications that help manage symptoms of Alzheimer’s Disease dementia by affecting certain chemicals in the brain
You must have a study partner who spends enough time with you to know about your daily activities, behavior, and overall health. This person needs to be able to provide information about your memory, thinking, emotions, daily tasks, and general well-being throughout the study
Both men and women can participate in this study
Adults and elderly people can participate in this study

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this data
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation
The trial is designed for patients with Alzheimer’s disease dementia, which is a brain condition that affects memory and thinking abilities
Participants must be taking acetylcholinesterase inhibitors, which are medications that help improve memory and thinking by increasing certain chemicals in the brain
The study includes both male and female participants
The study accepts adults and elderly patients, but does not include children or adolescents

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Brain Research Center Amsterdam B.V.	Amsterdam	The Netherlands
Brain Research Center Zwolle B.V.	Zwolle	The Netherlands
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli	Brescia	Italy
Phpwlqd Tpixy &ioap Rwymbfpkxhv Bnlv	Beek Lb	The Netherlands
Hqfenzhc Df Ld Ssrvb Cqwx I Stvr Pua	Barcelona	Spain
Htlvttvd Vhzu dvfadxmi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.04.2025
Spain	Not recruiting	01.04.2025
The Netherlands	Not recruiting	01.04.2025

Trial locations

Investigated drugs:

Mk-1167

MK-1167 is an investigational medication being tested as an additional treatment for people with mild to moderate Alzheimer’s disease dementia. In this study, it is given alongside standard Alzheimer’s medications called acetylcholinesterase inhibitors to see if it can provide extra benefits in improving memory and thinking abilities.

Acetylcholinesterase inhibitors are medications commonly prescribed to treat Alzheimer’s disease. They work by preventing the breakdown of a chemical in the brain that is important for memory and thinking. In this study, all participants continue taking their regular acetylcholinesterase inhibitor medication while also receiving either the study medication or placebo.

Placebo is an inactive substance that looks like the study medication but contains no active ingredients. It is used to compare whether the study medication has a real effect beyond what might happen naturally or from the standard treatment alone.

Alzheimer’s Disease Dementia – Alzheimer’s disease dementia is a brain disorder that gradually destroys memory and thinking skills. It is the most common cause of dementia, which refers to a decline in mental abilities severe enough to interfere with daily life. The disease typically begins with mild memory loss, especially of recent events, and progresses to affect language, reasoning, and the ability to perform everyday tasks. As the condition advances, individuals may experience confusion, disorientation, mood changes, and difficulty recognizing family members. Brain cells deteriorate over time, leading to shrinkage of brain tissue. The progression occurs slowly over several years, with symptoms becoming increasingly severe and affecting a person’s ability to function independently.

Trial ID:

2024-515539-31-00

Protocol code:

MK-1167-008

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing MK-1167 added to current treatment in patients with mild to moderate Alzheimer’s disease dementia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?