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ACTIVE NOT RECRUITING
NCT06721156
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-12-16

Completion Date

2026-12-31

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

MK-1167

MK-1167 oral capsule

DRUG

Placebo

Placebo oral capsule

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