A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)
NCT ID: NCT06721156
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
350 participants
INTERVENTIONAL
2024-12-16
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MK-1167 3 mg
Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.
MK-1167
MK-1167 oral capsule
MK-1167 1 mg
Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.
MK-1167
MK-1167 oral capsule
MK-1167 0.3 mg
Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
MK-1167
MK-1167 oral capsule
Placebo
Participants take placebo QD for up to approximately 24 weeks.
Placebo
Placebo oral capsule
Interventions
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MK-1167
MK-1167 oral capsule
Placebo
Placebo oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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 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
55 Years
90 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
Buenos Aires, Buenos Aires F.D., 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
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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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2024-515539-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-3391
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031240682
Identifier Type: REGISTRY
Identifier Source: secondary_id
1167-008
Identifier Type: -
Identifier Source: org_study_id
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