A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)

Launched by MERCK SHARP & DOHME LLC · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called MK-1167 to see if it can help improve memory and thinking skills in people with Alzheimer's disease dementia. Alzheimer's disease is the most common type of dementia, and the standard treatment often includes a type of medication called acetylcholinesterase inhibitors (AChEIs). The researchers want to find out if adding MK-1167 to this standard treatment can make a difference in how well people remember things and think clearly. They will also look at how safe MK-1167 is and how well people tolerate it.

To participate in this study, individuals must be diagnosed with mild to moderate Alzheimer's disease dementia and currently be using AChEI therapy. They should have a specific score on a memory test called the Mini-Mental State Examination (MMSE), which measures mental ability. Participants will need a study partner—someone who can spend time with them and help provide information about their daily life and health. The trial is currently recruiting participants, and anyone interested should check if they meet the eligibility criteria. Throughout the study, participants will be monitored closely to assess both the effects of the medication and their overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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