--- title: "A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)" nct_id: NCT06721156 overall_status: ACTIVE_NOT_RECRUITING phase: PHASE2 sponsor: Merck Sharp & Dohme LLC study_type: INTERVENTIONAL primary_condition: Alzheimer Disease countries: United States, Argentina, Canada, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06721156.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06721156" ct_last_update_post_date: 2026-03-16 last_seen_at: "2026-05-12T06:22:44.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008) **Official Title:** 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 **NCT ID:** [NCT06721156](https://clinicaltrials.gov/study/NCT06721156) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 350 - **Lead Sponsor:** Merck Sharp & Dohme LLC - **Conditions:** Alzheimer Disease, Dementia - **Start Date:** 2024-12-16 - **Completion Date:** 2026-12-31 - **CT.gov Last Update:** 2026-03-16 ## Brief Summary 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 ## Eligibility - **Minimum age:** 55 Years - **Maximum age:** 90 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **MK-1167 3 mg** (EXPERIMENTAL) — Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks. - **MK-1167 1 mg** (EXPERIMENTAL) — Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks. - **MK-1167 0.3 mg** (EXPERIMENTAL) — Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks. - **Placebo** (PLACEBO_COMPARATOR) — Participants take placebo QD for up to approximately 24 weeks. ## Interventions - **MK-1167** (DRUG) — MK-1167 oral capsule - **Placebo** (DRUG) — Placebo oral capsule ## Primary Outcomes - **Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24** _(time frame: Baseline and up to approximately 24 weeks)_ — The change from baseline in ADAS-Cog11 score at Week 24 is presented. ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa. - **Number of Participants Who Experience One or More Adverse Events (AEs)** _(time frame: Up to approximately 28 weeks)_ — An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. - **Number of Participants Who Discontinue Study Intervention Due to an AE** _(time frame: Up to approximately 24 weeks)_ — An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. ## Secondary Outcomes - **Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24** _(time frame: Baseline and up to approximately 24 weeks)_ - **Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24** _(time frame: Baseline and up to approximately 24 weeks)_ - **Change From Baseline in the ADAS-Cog11 Total Score at Week 12** _(time frame: Baseline and up to approximately 12 weeks)_ - **ADCS-CGIC Overall Score at Week 12** _(time frame: Baseline and up to approximately 12 weeks)_ - **Change From Baseline in the ADCS-ADL Total Score at Week 12** _(time frame: Baseline and up to approximately 12 weeks)_ ## Locations (72) - Banner Alzheimer's Institute ( Site 0110), Phoenix, Arizona, United States - 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 - Kerwin Medical Center ( Site 0159), Dallas, Texas, United States - Grayline Research Center ( Site 0105), Wichita Falls, Texas, United States - Northwest Clinical Research Center ( Site 0102), Bellevue, Washington, United States - Instituto de Investigaciones Clínicas Mar del Plata ( Site 0207), Mar del Plata, Buenos Aires, Argentina - Hospital Italiano de Buenos Aires ( Site 0209), Buenos Aires, Buenos Aires F.D., Argentina - Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208), Buenos Aires, Buenos Aires F.D., Argentina - Organizacion Medica de Investigacion - OMI S.A. ( Site 0204), Buenos Aires, Argentina - Instituto Kremer ( Site 0202), Córdoba, Argentina - Okanagan Clinical Trials ( Site 0001), Kelowna, British Columbia, Canada - Ottawa Memory Clinic ( Site 0004), Ottawa, Ontario, Canada - Toronto Memory Program ( Site 0006), Toronto, Ontario, Canada - Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903), Milan, Lombardy, Italy - Fondazione IRCCS San Gerardo dei Tintori ( Site 0902), Monza, Monza E Brianza, Italy - Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904), Brescia, Italy - Ospedale San Raffaele. ( Site 0901), Milan, Italy - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905), Roma, Italy - Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510), Kawasaki, Kanagawa, Japan - Kawasaki Saiwai Clinic ( Site 1501), Kawasaki, Kanagawa, Japan - Hatsuta Neurology Clinic ( Site 1507), Hirakata, Osaka, Japan - Nagomi Clinic ( Site 1506), Toyonaka, Osaka, Japan - Takesato Hospital ( Site 1522), Kasukabe, Saitama, Japan - Iwaki Clinic ( Site 1518), Anan, Tokushima, Japan - Enomoto Internal Medicine Clinic(Chofu) ( Site 1503), Chōfu, Tokyo, Japan - Nozomi Memory Clinic ( Site 1504), Mitaka, Tokyo, Japan - Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515), tabashi City, Tokyo, Japan - Itsuki Hospital ( Site 1502), Tokushima, Japan - Brain Research Center Den Bosch B.V. ( Site 1002), 's-Hertogenbosch, North Brabant, Netherlands - Brain Research Center. ( Site 1001), Amsterdam, North Holland, Netherlands - Brain Research Center Zwolle ( Site 1003), Zwolle, Overijssel, Netherlands - Inha University Hospital ( Site 1601), Incheon, South Korea - Seoul National University Hospital ( Site 1604), Seoul, South Korea - Hanyang University Seoul Hospital ( Site 1605), Seoul, South Korea - Asan Medical Center ( Site 1603), Seoul, South Korea - Centro de Atención Especializada Oroitu ( Site 1211), Algorta, Bizkaia, Spain - Hospital de la Santa Creu i Sant Pau ( Site 1204), Barcelona, Catalonia, Spain - Hospital Universitario 12 de Octubre ( Site 1208), Madrid, Madrid, Comunidad de, Spain - Hospital Universitari i Politecnic La Fe ( Site 1202), Valencia, Valencia, Spain - Fundació ACE ( Site 1206), Barcelona, Spain - Hospital Universitari Vall D Hebron ( Site 1203), Barcelona, Spain - Hospital Universitario Virgen de la Macarena ( Site 1210), Seville, Spain - Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402), Aberdeen, Aberdeen City, United Kingdom - Scottish Brain Sciences ( Site 1401), Edinburgh, Edinburgh, City of, United Kingdom - Moorgreen Hospital ( Site 1409), Southampton, Hampshire, United Kingdom - Remind UK ( Site 1404), Bath, Somerset, United Kingdom - Re:Cognition Health - Birmingham ( Site 1406), Birmingham, United Kingdom - Windsor Research Unit ( Site 1403), Cambridge, United Kingdom - Campus for Ageing and Vitality ( Site 1408), Newcastle upon Tyne, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.banner alzheimer's institute ( site 0110)|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.irvine clinical research ( site 0104)|irvine|california|united states` — added _(2026-05-12)_ - `locations.anderson clinical research ( site 0164)|redlands|california|united states` — added _(2026-05-12)_ - `locations.california neuroscience research ( site 0118)|sherman oaks|california|united states` — added _(2026-05-12)_ - `locations.jem research institute / headlands research network ( site 0108)|atlantis|florida|united states` — added _(2026-05-12)_ - `locations.brain matters research-neurology ( site 0150)|delray beach|florida|united states` — added _(2026-05-12)_ - `locations.neuropsychiatric research center of southwest florida ( site 0152)|fort myers|florida|united states` — added _(2026-05-12)_ - `locations.indago research & health center, inc ( site 0128)|hialeah|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research the villages ( site 0166)|lady lake|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research ( site 0103)|maitland|florida|united states` — added _(2026-05-12)_ - `locations.premier clinical research institute ( site 0114)|miami|florida|united states` — added _(2026-05-12)_ - `locations.aqualane clinical research ( site 0116)|naples|florida|united states` — added _(2026-05-12)_ - `locations.headlands research orlando ( site 0169)|orlando|florida|united states` — added _(2026-05-12)_ - `locations.brain matters research ( site 0151)|stuart|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research ( site 0165)|tampa|florida|united states` — added _(2026-05-12)_ - `locations.columbus memory center ( site 0197)|columbus|georgia|united states` — added _(2026-05-12)_ - `locations.cenexel iresearch, llc ( site 0134)|savannah|georgia|united states` — added _(2026-05-12)_ - `locations.tandem clinical research ( site 0101)|marrero|louisiana|united states` — added _(2026-05-12)_ - `locations.pharmasite research, inc. ( site 0167)|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.quest research institute ( site 0173)|farmington hills|michigan|united states` — added _(2026-05-12)_ - `locations.velocity clinical research, syracuse ( site 0125)|east syracuse|new york|united states` — added _(2026-05-12)_ - `locations.mid hudson medical research ( site 0191)|new windsor|new york|united states` — added _(2026-05-12)_ - `locations.flourish research - charlotte ( site 0106)|matthews|north carolina|united states` — added _(2026-05-12)_ - `locations.velocity clinical research - raleigh ( site 0123)|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.summit research network ( site 0111)|portland|oregon|united states` — added _(2026-05-12)_ - `locations.kerwin medical center ( site 0159)|dallas|texas|united states` — added _(2026-05-12)_ - `locations.grayline research center ( site 0105)|wichita falls|texas|united states` — added _(2026-05-12)_ - `locations.northwest clinical research center ( site 0102)|bellevue|washington|united states` — added _(2026-05-12)_ - `locations.instituto de investigaciones clínicas mar del plata ( site 0207)|mar del plata|buenos aires|argentina` — added _(2026-05-12)_ - `locations.hospital italiano de buenos aires ( site 0209)|buenos aires|buenos aires f.d.|argentina` — added _(2026-05-12)_ - `locations.instituto geriatrico nuestra señora de las nieves ( site 0208)|buenos aires|buenos aires f.d.|argentina` — added _(2026-05-12)_ - `locations.organizacion medica de investigacion - omi s.a. ( site 0204)|buenos aires||argentina` — added _(2026-05-12)_ - `locations.instituto kremer ( site 0202)|córdoba||argentina` — added _(2026-05-12)_ - `locations.okanagan clinical trials ( site 0001)|kelowna|british columbia|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06721156.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06721156* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*