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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
EU CTIS ID: 2024-515539-31-00
What this study is testing
1. To assess the efficacy of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors on the ADAS-Cog11 Total Score compared with placebo at Week 24. 2. To evaluate the safety and tolerability of MK-1167 as adjunctive therapy to acetylcholinesterase inhibitors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has mild to moderate Alzheimer’s Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer’s Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
- Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
- Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
- Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status
You likely can't join if
- Has a known history of stroke or cerebrovascular disease
- Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically
- Has structural brain disease
- Has a history of seizures or epilepsy
- Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)
- Has major medical illness or unstable medical condition
See the full eligibility criteria
- Has mild to moderate Alzheimer’s Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer’s Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
- Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
- Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
- Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status
- Has a known history of stroke or cerebrovascular disease
- Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically
- Has structural brain disease
- Has a history of seizures or epilepsy
- Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)
- Has major medical illness or unstable medical condition
- Has a history of malignancy
- Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
- Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
- Korea, Republic of
- Japan
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States; Korea, Republic of; Japan; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.