Evaluating MK-1167 for Alzheimer's Disease Dementia

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

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06721156

This study is testing if a new drug called MK-1167 can improve memory and thinking skills in people with mild to moderate Alzheimer's disease who are already on other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment350 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations57 sites (Phoenix, Arizona and 56 other locations)
Trial IDNCT06721156 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of MK-1167 in participants with mild to moderate Alzheimer's disease dementia who are already receiving acetylcholinesterase inhibitor therapy. Researchers will compare the effects of MK-1167 against a placebo to determine if it can enhance memory and cognitive function. The study will also monitor the safety and tolerability of MK-1167 in this patient population. Participants will need a study partner to provide insights into their daily functioning and health status.

Who should consider this trial

Good fit: Ideal candidates are individuals with mild to moderate Alzheimer's disease dementia who are currently on acetylcholinesterase inhibitors.

Not a fit: Patients with a history of stroke or significant central nervous system disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cognitive symptoms in patients with Alzheimer's disease dementia.

How similar studies have performed: Previous studies have shown promise in enhancing cognitive function in Alzheimer's patients with similar therapeutic approaches, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Alzheimer DiseaseDementia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.