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

NCT06721156 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: 1167-0082024-515539-31-00U1111-1309-3391jRCT2031240682
• Study Type: interventional
• Target: 350
• Locations: 9 countries
• Sites: 72

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

Conditions

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24

  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.

  Baseline and up to approximately 24 weeks

• Number of Participants Who Experience One or More Adverse Events (AEs)

  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.

  Up to approximately 28 weeks

• Number of Participants Who Discontinue Study Intervention Due to an AE

  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.

  Up to approximately 24 weeks

Secondary Outcomes (5)

• Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24

  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

  Baseline and up to approximately 24 weeks

• Change From Baseline in the ADAS-Cog11 Total Score at Week 12

  Baseline and up to approximately 12 weeks

• ADCS-CGIC Overall Score at Week 12

  Baseline and up to approximately 12 weeks

• Change From Baseline in the ADCS-ADL Total Score at Week 12

  Baseline and up to approximately 12 weeks

Study Arms (4)

MK-1167 3 mg

EXPERIMENTAL

Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.

Drug: MK-1167

MK-1167 1 mg

EXPERIMENTAL

Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.

Drug: MK-1167

MK-1167 0.3 mg

EXPERIMENTAL

Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.

Drug: MK-1167

Placebo

PLACEBO COMPARATOR

Participants take placebo QD for up to approximately 24 weeks.

Drug: Placebo

Interventions

MK-1167 DRUG

MK-1167 oral capsule

MK-1167 0.3 mg; MK-1167 1 mg; MK-1167 3 mg

Placebo DRUG

Placebo oral capsule

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (72)

Banner Alzheimer's Institute ( Site 0110)

Phoenix, Arizona, 85006, United States

Location

Irvine Clinical Research ( Site 0104)

Irvine, California, 92614, United States

Location

Anderson Clinical Research ( Site 0164)

Redlands, California, 92374, United States

Location

California Neuroscience Research ( Site 0118)

Sherman Oaks, California, 91403, United States

Location

JEM Research Institute / Headlands Research Network ( Site 0108)

Atlantis, Florida, 33462, United States

Location

Brain Matters Research-Neurology ( Site 0150)

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida ( Site 0152)

Fort Myers, Florida, 33912, United States

Location

Indago Research & Health Center, Inc ( Site 0128)

Hialeah, Florida, 33012, United States

Location

K2 Medical Research THE VILLAGES ( Site 0166)

Lady Lake, Florida, 32159, United States

Location

K2 Medical Research ( Site 0103)

Maitland, Florida, 32750, United States

Location

Premier Clinical Research Institute ( Site 0114)

Miami, Florida, 33122, United States

Location

Aqualane Clinical Research ( Site 0116)

Naples, Florida, 34105, United States

Location

Headlands Research Orlando ( Site 0169)

Orlando, Florida, 32806, United States

Location

Brain Matters Research ( Site 0151)

Stuart, Florida, 34997, United States

Location

K2 Medical Research ( Site 0165)

Tampa, Florida, 33634, United States

Location

Columbus Memory Center ( Site 0197)

Columbus, Georgia, 31909, United States

Location

CenExel iResearch, LLC ( Site 0134)

Savannah, Georgia, 31405, United States

Location

Tandem Clinical Research ( Site 0101)

Marrero, Louisiana, 70072, United States

Location

Pharmasite Research, Inc. ( Site 0167)

Baltimore, Maryland, 21208, United States

Location

Quest Research Institute ( Site 0173)

Farmington Hills, Michigan, 48334, United States

Location

Velocity Clinical Research, Syracuse ( Site 0125)

East Syracuse, New York, 13057, United States

Location

Mid Hudson Medical Research ( Site 0191)

New Windsor, New York, 12553, United States

Location

Flourish Research - Charlotte ( Site 0106)

Matthews, North Carolina, 28105, United States

Location

Velocity Clinical Research - Raleigh ( Site 0123)

Raleigh, North Carolina, 27607, United States

Location

Summit Research Network ( Site 0111)

Portland, Oregon, 97210, United States

Location

Kerwin Medical Center ( Site 0159)

Dallas, Texas, 75231, United States

Location

Grayline Research Center ( Site 0105)

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center ( Site 0102)

Bellevue, Washington, 98007, United States

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0207)

Mar del Plata, Buenos Aires, B7600FZN, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 0209)

Buenos Aires, Buenos Aires F.D., C1199ABD, Argentina

Location

Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)

Buenos Aires, Buenos Aires F.D., C1427CCP, Argentina

Location

Organizacion Medica de Investigacion - OMI S.A. ( Site 0204)

Buenos Aires, C1015ABO, Argentina

Location

Instituto Kremer ( Site 0202)

Córdoba, X5004AOA, Argentina

Location

Okanagan Clinical Trials ( Site 0001)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Ottawa Memory Clinic ( Site 0004)

Ottawa, Ontario, K1Z 1G3, Canada

Location

Toronto Memory Program ( Site 0006)

Toronto, Ontario, M3B 2S7, Canada

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903)

Milan, Lombardy, 20122, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)

Monza, Monza E Brianza, 20900, Italy

Location

Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)

Brescia, 25125, Italy

Location

Ospedale San Raffaele. ( Site 0901)

Milan, 20132, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)

Roma, 00168, Italy

Location

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)

Kawasaki, Kanagawa, 210-0852, Japan

Location

Kawasaki Saiwai Clinic ( Site 1501)

Kawasaki, Kanagawa, 212-0016, Japan

Location

Hatsuta Neurology Clinic ( Site 1507)

Hirakata, Osaka, 573-1121, Japan

Location

Nagomi Clinic ( Site 1506)

Toyonaka, Osaka, 560-0004, Japan

Location

Takesato Hospital ( Site 1522)

Kasukabe, Saitama, 344-0036, Japan

Location

Iwaki Clinic ( Site 1518)

Anan, Tokushima, 774-0014, Japan

Location

Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)

Chōfu, Tokyo, 182-0036, Japan

Location

Nozomi Memory Clinic ( Site 1504)

Mitaka, Tokyo, 181-0013, Japan

Location

Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)

tabashi City, Tokyo, 173-0015, Japan

Location

Itsuki Hospital ( Site 1502)

Tokushima, 770-0852, Japan

Location

Brain Research Center Den Bosch B.V. ( Site 1002)

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands

Location

Brain Research Center. ( Site 1001)

Amsterdam, North Holland, 1081 GN, Netherlands

Location

Brain Research Center Zwolle ( Site 1003)

Zwolle, Overijssel, 8025 AZ, Netherlands

Location

Inha University Hospital ( Site 1601)

Incheon, 22332, South Korea

Location

Seoul National University Hospital ( Site 1604)

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital ( Site 1605)

Seoul, 04763, South Korea

Location

Asan Medical Center ( Site 1603)

Seoul, 05505, South Korea

Location

Centro de Atención Especializada Oroitu ( Site 1211)

Algorta, Bizkaia, 48993, Spain

Location

Hospital de la Santa Creu i Sant Pau ( Site 1204)

Barcelona, Catalonia, 8025, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1208)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitari i Politecnic La Fe ( Site 1202)

Valencia, Valencia, 46026, Spain

Location

Fundació ACE ( Site 1206)

Barcelona, 08034, Spain

Location

Hospital Universitari Vall D Hebron ( Site 1203)

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de la Macarena ( Site 1210)

Seville, 41009, Spain

Location

Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402)

Aberdeen, Aberdeen City, AB25 2XE, United Kingdom

Location

Scottish Brain Sciences ( Site 1401)

Edinburgh, Edinburgh, City of, EH12 5PJ, United Kingdom

Location

Moorgreen Hospital ( Site 1409)

Southampton, Hampshire, SO30 3JB, United Kingdom

Location

Remind UK ( Site 1404)

Bath, Somerset, BA1 3NG, United Kingdom

Location

Re:Cognition Health - Birmingham ( Site 1406)

Birmingham, B16 8LT, United Kingdom

Location

Windsor Research Unit ( Site 1403)

Cambridge, CB21 5EF, United Kingdom

Location

Campus for Ageing and Vitality ( Site 1408)

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (3); AR (5); CA (3); GB (7); US (28); ES (7); KR (4); JP (10); IT (5)