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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease, Dementia

In brief

Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia. The goals of this study are to learn: * If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo * About the safety of MK-1167 and if people tolerate it

Key facts

Study ID

NCT06721156

Run by

Merck Sharp & Dohme LLC

People needed

369

Starts

2024-12-16

Expected to finish

2026-06-05

Last updated by the study team

2026-07-01

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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
• 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

Where it is running

• Irvine Clinical Research ( Site 0104) — Irvine, California, United States
• Anderson Clinical Research ( Site 0164) — Redlands, California, United States
• California Neuroscience Research ( Site 0118) — Sherman Oaks, California, United States
• JEM Research Institute / Headlands Research Network ( Site 0108) — Atlantis, Florida, United States
• Brain Matters Research-Neurology ( Site 0150) — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida ( Site 0152) — Fort Myers, Florida, United States
• Indago Research & Health Center, Inc ( Site 0128) — Hialeah, Florida, United States
• K2 Medical Research THE VILLAGES ( Site 0166) — Lady Lake, Florida, United States
• K2 Medical Research ( Site 0103) — Maitland, Florida, United States
• Premier Clinical Research Institute ( Site 0114) — Miami, Florida, United States
• Aqualane Clinical Research ( Site 0116) — Naples, Florida, United States
• Headlands Research Orlando ( Site 0169) — Orlando, Florida, United States
• Brain Matters Research ( Site 0151) — Stuart, Florida, United States
• K2 Medical Research ( Site 0165) — Tampa, Florida, United States
• Columbus Memory Center ( Site 0197) — Columbus, Georgia, United States
• CenExel iResearch, LLC ( Site 0134) — Savannah, Georgia, United States
• Tandem Clinical Research ( Site 0101) — Marrero, Louisiana, United States
• Pharmasite Research, Inc. ( Site 0167) — Baltimore, Maryland, United States
• Quest Research Institute ( Site 0173) — Farmington Hills, Michigan, United States
• Velocity Clinical Research, Syracuse ( Site 0125) — East Syracuse, New York, United States
• Mid Hudson Medical Research ( Site 0191) — New Windsor, New York, United States
• Flourish Research - Charlotte ( Site 0106) — Matthews, North Carolina, United States
• Velocity Clinical Research - Raleigh ( Site 0123) — Raleigh, North Carolina, United States
• Summit Research Network ( Site 0111) — Portland, Oregon, United States
• Banner Alzheimer's Institute ( Site 0110) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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