A study to evaluate the efficacy and safety of MK-1167 in participants with Alzheimer's disease dementia
Information about the drug that will be tested in the study
Administration
Oral capsule once daily
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- Oral capsules of MK-1167 (3mg)
- Oral capsules of MK-1167 (1mg)
- Oral capsules of MK-1167 (0.3mg)
- Oral capsules of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The study will evaluate the safety and efficacy of MK-1167 as adjunctive therapy in people with mild to moderate Alzheimer's disease dementia. Researchers want to learn if giving MK-1167 along with acetylcholinesterase inhibitor therapy can improve symptoms of Alzheimer's disease dementia, such as memory and mental activity.
How long will the treatment last?
- The treatment will last 6 months
- Before the treatment period, the participant will take part in a screening period of up to 3 months
- After the end of treatment, participants will be followed for 1 month.
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their memory, cognition, functional, behaviour and activities of daily living (ADAS-Cog11, ADCS-CGIC, ADCS-AD, ADCS-CGIC, ADCS-ADL)
- Complete some laboratory tests and neurological examination to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 55 and 90 years old
- Have a diagnosis of mild to moderate Alzheimer's disease dementia, based on the Alzheimer's Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
- Have a score between 12-24 in the MMSE score. This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
- Use acetylcholinesterase inhibitors therapy for management of Alzheimer's disease dementia (i.e. donepezil, rivastigmine and galantamine)
- Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Diagnosis of a clinically relevant central nervous system disease other than Alzheimer’s disease dementia or major brain trauma that negatively impacts cognition or cognitive status chronically
- A disease that may interfere with the safety or study assessments (e.g., Human immunodeficiency virus, syphilis, hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases)
- Major medical illness or unstable medical condition
- History of malignancy, stroke, cerebrovascular disease, seizures or epilepsy
- Residence in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EuCT Number
2024-515539-31-00
Clinicaltrials.gov identifier
NCT06721156
Study contact information
Link to full text
https://euclinicaltrials.eu/ctis-public/view/2024-515539-31-00
https://clinicaltrials.gov/study/NCT06721156
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in September 2025.
This document has been reviewed by the pharmaceutical company running this trial.
