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
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 57 sites (Phoenix, Arizona and 56 other locations) |
| Trial ID | NCT06721156 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
- Banner Alzheimer's Institute ( Site 0110) — Phoenix, Arizona, United States (Recruiting)
- Irvine Clinical Research ( Site 0104) — Irvine, California, United States (Recruiting)
- Anderson Clinical Research ( Site 0164) — Redlands, California, United States (Recruiting)
- California Neuroscience Research ( Site 0118) — Sherman Oaks, California, United States (Recruiting)
- JEM Research Institute / Headlands Research Network ( Site 0108) — Atlantis, Florida, United States (Recruiting)
- Brain Matters Research-Neurology ( Site 0150) — Delray Beach, Florida, United States (Recruiting)
- Neuropsychiatric Research Center of Southwest Florida ( Site 0152) — Fort Myers, Florida, United States (Recruiting)
- Indago Research & Health Center, Inc ( Site 0128) — Hialeah, Florida, United States (Recruiting)
- K2 Medical Research THE VILLAGES ( Site 0166) — Lady Lake, Florida, United States (Recruiting)
- K2 Medical Research ( Site 0103) — Maitland, Florida, United States (Recruiting)
- Premier Clinical Research Institute ( Site 0114) — Miami, Florida, United States (Recruiting)
- Aqualane Clinical Research ( Site 0116) — Naples, Florida, United States (Recruiting)
- Headlands Research Orlando ( Site 0169) — Orlando, Florida, United States (Recruiting)
- Brain Matters Research ( Site 0151) — Stuart, Florida, United States (Recruiting)
- K2 Medical Research Tampa LLC ( Site 0165) — Tampa, Florida, United States (Recruiting)
- Columbus Memory Center ( Site 0197) — Columbus, Georgia, United States (Recruiting)
- CenExel iResearch, LLC ( Site 0134) — Savannah, Georgia, United States (Recruiting)
- Tandem Clinical Research ( Site 0101) — Marrero, Louisiana, United States (Recruiting)
- Pharmasite Research, Inc. ( Site 0167) — Baltimore, Maryland, United States (Recruiting)
- Quest Research Institute ( Site 0173) — Farmington Hills, Michigan, United States (Recruiting)
- Velocity Clinical Research, Syracuse ( Site 0125) — East Syracuse, New York, United States (Recruiting)
- Mid Hudson Medical Research ( Site 0191) — New Windsor, New York, United States (Recruiting)
- Flourish Research - Charlotte ( Site 0106) — Matthews, North Carolina, United States (Recruiting)
- Velocity Clinical Research - Raleigh ( Site 0123) — Raleigh, North Carolina, United States (Recruiting)
- Summit Research Network ( Site 0111) — Portland, Oregon, United States (Recruiting)
- Kerwin Medical Center ( Site 0159) — Dallas, Texas, United States (Recruiting)
- Grayline Research Center ( Site 0105) — Wichita Falls, Texas, United States (Recruiting)
- Northwest Clinical Research Center ( Site 0102) — Bellevue, Washington, United States (Recruiting)
- Okanagan Clinical Trials ( Site 0001) — Kelowna, British Columbia, Canada (Recruiting)
- Ottawa Memory Clinic ( Site 0004) — Ottawa, Ontario, Canada (Recruiting)
- Toronto Memory Program ( Site 0006) — Toronto, Ontario, Canada (Recruiting)
- Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904) — Brescia, Italy (Recruiting)
- Ospedale San Raffaele. ( Site 0901) — Milano, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905) — Roma, Italy (Recruiting)
- Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510) — Kawasaki, Kanagawa, Japan (Recruiting)
- Kawasaki Saiwai Clinic ( Site 1501) — Kawasaki, Kanagawa, Japan (Recruiting)
- Hatsuta Neurology Clinic ( Site 1507) — Hirakata, Osaka, Japan (Recruiting)
- Nagomi Clinic ( Site 1506) — Toyonaka, Osaka, Japan (Recruiting)
- Takesato Hospital ( Site 1522) — Kasukabe, Saitama, Japan (Recruiting)
- Iwaki Clinic ( Site 1518) — Anan, Tokushima, Japan (Recruiting)
- Enomoto Internal Medicine Clinic(Chofu) ( Site 1503) — Chofu, Tokyo, Japan (Recruiting)
- Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515) — Itabashi, Tokyo, Japan (Recruiting)
- Nozomi Memory Clinic ( Site 1504) — Mitaka, Tokyo, Japan (Recruiting)
- Itsuki Hospital ( Site 1502) — Tokushima, Japan (Recruiting)
- Inha University Hospital ( Site 1601) — Incheon, Korea, Republic of (Recruiting)
- Seoul National University Hospital ( Site 1604) — Seoul, Korea, Republic of (Recruiting)
- Hanyang University Seoul Hospital ( Site 1605) — Seoul, Korea, Republic of (Recruiting)
- Brain Research Center Den Bosch B.V. ( Site 1002) — Den Bosch, Noord-Brabant, Netherlands (Recruiting)
- Brain Research Center. ( Site 1001) — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Brain Research Center Zwolle ( Site 1003) — Zwolle, Overijssel, Netherlands (Recruiting)
+7 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.