Ph 2 Study of MK-1167 in Ppts with Mild-Moderate Alzheimer’s Disease
Research type
Research Study
Full title
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
IRAS ID
1010891
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for new ways to treat people with mild to moderate Alzheimer’s disease dementia (AD dementia). AD dementia causes a loss of memory, communication (such as speech), and decision making that can limit a person’s ability to do daily tasks. Standard treatment for AD dementia is acetylcholinesterase inhibitor (AChEI) therapy however, AChEI therapy alone may not fully treat AD dementia symptoms.
Researchers want to learn if giving MK-1167 along with AChEI therapy can treat AD dementia.
The goals of this study are to learn:
• If at least one dose level of MK-1167 works to improve a person’s memory and thinking compared to a placebo. A placebo looks like the study medicine but has no study medicine in it. Using a placebo will help researchers better understand the effects of the study medicine.
• About the safety of MK-1167 and if people tolerate it
About 350 people (aged 55 to 90 years old) with mild to moderate AD dementia will take part and:
• Take certain AChEI therapy for AD dementia
• Do not have other types of dementia or brain diseases
• Have not had certain types of cancer 5 years before starting the study
Each person will have a study partner who will go with them to all study visits and answer study questions. The study partner will be someone who knows the person’s ability to do daily tasks.
People will take their assigned treatment (MK-1167 or Placebo) by mouth, as capsules, once a day for 6 months. People will also continue to take their AChEI therapy during the study.
People will be assigned by chance to one of these treatment groups:
• Group 1 will take a low dose MK-1167. There will be less people in Group 1 than the other groups.
• Group 2 will take a medium dose MK-1167
• Group 3 will take a high dose MK-1167
• Group 4 will take placebo
Neither the people in the study nor the researchers will know which treatment a person takes (double-blind).
People will be in this study for about 9 months.REC name
Wales REC 2
REC reference
25/WA/0039
Date of REC Opinion
9 May 2025
REC opinion
Further Information Favourable Opinion