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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Drug: Placebo; Drug: MK-1167

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion - OMI S.A. ( Site 0204)
  • Córdoba, Argentina, X5004AOA
    • Instituto Kremer ( Site 0202)
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0207)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1199ABD
      • Hospital Italiano de Buenos Aires ( Site 0209)
    • Buenos Aires, Buenos Aires F.D., Argentina, C1427CCP
      • Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Okanagan Clinical Trials ( Site 0001)
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 1G3
      • Ottawa Memory Clinic ( Site 0004)
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program ( Site 0006)
• Italy
  • Brescia, Italy, 25125
    • Centro S Giovanni Di Dio Fatebenefratelli ( Site 0904)
  • Milan, Italy, 20132
    • Ospedale San Raffaele. ( Site 0901)
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0905)
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 0903)
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori ( Site 0902)
• Japan
  • Tokushima, Japan, 770-0852
    • Itsuki Hospital ( Site 1502)
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 210-0852
      • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 1510)
    • Kawasaki, Kanagawa, Japan, 212-0016
      • Kawasaki Saiwai Clinic ( Site 1501)
  • Osaka
    • Hirakata, Osaka, Japan, 573-1121
      • Hatsuta Neurology Clinic ( Site 1507)
    • Toyonaka, Osaka, Japan, 560-0004
      • Nagomi Clinic ( Site 1506)
  • Saitama
    • Kasukabe, Saitama, Japan, 344-0036
      • Takesato Hospital ( Site 1522)
  • Tokushima
    • Anan, Tokushima, Japan, 774-0014
      • Iwaki Clinic ( Site 1518)
  • Tokyo
    • Chōfu, Tokyo, Japan, 182-0036
      • Enomoto Internal Medicine Clinic(Chofu) ( Site 1503)
    • Mitaka, Tokyo, Japan, 181-0013
      • Nozomi Memory Clinic ( Site 1504)
    • tabashi City, Tokyo, Japan, 173-0015
      • Tokyo Metropolitan Institute for Geriatrics and Gerontology ( Site 1515)
• Netherlands
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
      • Brain Research Center Den Bosch B.V. ( Site 1002)
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 GN
      • Brain Research Center. ( Site 1001)
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AZ
      • Brain Research Center Zwolle ( Site 1003)
• South Korea
  • Incheon, South Korea, 22332
    • Inha University Hospital ( Site 1601)
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 1604)
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital ( Site 1605)
  • Seoul, South Korea, 05505
    • Asan Medical Center ( Site 1603)
• Spain
  • Barcelona, Spain, 08034
    • Fundació ACE ( Site 1206)
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall D Hebron ( Site 1203)
  • Seville, Spain, 41009
    • Hospital Universitario Virgen de la Macarena ( Site 1210)
  • Bizkaia
    • Algorta, Bizkaia, Spain, 48993
      • Centro de Atención Especializada Oroitu ( Site 1211)
  • Catalonia
    • Barcelona, Catalonia, Spain, 8025
      • Hospital de la Santa Creu i Sant Pau ( Site 1204)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre ( Site 1208)
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Hospital Universitari i Politecnic La Fe ( Site 1202)
• United Kingdom
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health - Birmingham ( Site 1406)
  • Cambridge, United Kingdom, CB21 5EF
    • Windsor Research Unit ( Site 1403)
  • Newcastle upon Tyne, United Kingdom, NE4 5PL
    • Campus for Ageing and Vitality ( Site 1408)
  • Aberdeen City
    • Aberdeen, Aberdeen City, United Kingdom, AB25 2XE
      • Brain Sciences Scotland Life Sciences-Aberdeen ( Site 1402)
  • Edinburgh, City of
    • Edinburgh, Edinburgh, City of, United Kingdom, EH12 5PJ
      • Scottish Brain Sciences ( Site 1401)
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO30 3JB
      • Moorgreen Hospital ( Site 1409)
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 3NG
      • Remind UK ( Site 1404)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute ( Site 0110)
  • California
    • Irvine, California, United States, 92614
      • Irvine Clinical Research ( Site 0104)
    • Redlands, California, United States, 92374
      • Anderson Clinical Research ( Site 0164)
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research ( Site 0118)
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute / Headlands Research Network ( Site 0108)
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research-Neurology ( Site 0150)
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida ( Site 0152)
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 0128)
    • Lady Lake, Florida, United States, 32159
      • K2 Medical Research THE VILLAGES ( Site 0166)
    • Maitland, Florida, United States, 32750
      • K2 Medical Research ( Site 0103)
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute ( Site 0114)
    • Naples, Florida, United States, 34105
      • Aqualane Clinical Research ( Site 0116)
    • Orlando, Florida, United States, 32806
      • Headlands Research Orlando ( Site 0169)
    • Stuart, Florida, United States, 34997
      • Brain Matters Research ( Site 0151)
    • Tampa, Florida, United States, 33634
      • K2 Medical Research ( Site 0165)
  • Georgia
    • Columbus, Georgia, United States, 31909
      • Columbus Memory Center ( Site 0197)
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC ( Site 0134)
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research ( Site 0101)
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc. ( Site 0167)
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute ( Site 0173)
  • New York
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse ( Site 0125)
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research ( Site 0191)
  • North Carolina
    • Matthews, North Carolina, United States, 28105
      • Flourish Research - Charlotte ( Site 0106)
    • Raleigh, North Carolina, United States, 27607
      • Velocity Clinical Research - Raleigh ( Site 0123)
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network ( Site 0111)
  • Texas
    • Dallas, Texas, United States, 75231
      • Kerwin Medical Center ( Site 0159)
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center ( Site 0105)
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center ( Site 0102)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-1167 3 mg; Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.	Drug: MK-1167; MK-1167 oral capsule
Experimental: MK-1167 1 mg; Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.	Drug: MK-1167; MK-1167 oral capsule
Experimental: MK-1167 0.3 mg; Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.	Drug: MK-1167; MK-1167 oral capsule
Placebo Comparator: Placebo; Participants take placebo QD for up to approximately 24 weeks.	Drug: Placebo; Placebo oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24	The overall score in ADCS-CGIC at Week 24 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.	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	The change from baseline in ADCS-ADL score at Week 24 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.	Baseline and up to approximately 24 weeks
Change From Baseline in the ADAS-Cog11 Total Score at Week 12	The change from baseline in ADAS-Cog11 score at Week 12 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 12 weeks
ADCS-CGIC Overall Score at Week 12	The overall score in ADCS-CGIC at Week 12 is presented. The ADCS-CGIC is a clinician-rated measure of change in global severity from baseline, scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change. The assessment focuses on clinicians' observations of change in the participant's cognitive, functional, and behavioral performance since the beginning of the study.	Baseline and up to approximately 12 weeks
Change From Baseline in the ADCS-ADL Total Score at Week 12	The change from baseline in ADCS-ADL score at Week 12 is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living (ADLs). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23-item scale that includes 6 basic ADL items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.	Baseline and up to approximately 12 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 1167-008; U1111-1309-3391 (Registry Identifier: UTN); jRCT2031240682 (Registry Identifier: jRCT); 2024-515539-31-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No