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TerminatedPhase 2

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

Asset

MK-1167

Listed sites

72

Recruiting sites

-

Enrollment

369

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 12-24•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Number of Participants Who Experience One or More Adverse Events (AEs)•Number of Participants Who Discontinue Study Intervention Due to an AE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID1167-008
Registry2024-515539-31-00EU CT
RegistryjRCT2031240682jRCT
Secondary IDMK-1167-008MSD
NCT IDNCT06721156
RegistryU1111-1309-3391UTN

Timeline

Milestones

Study first posted2024-12-06actual
Study start2024-12-16actual
Primary completion2026-06-05actual
Study completion2026-06-05actual
Last update posted2026-07-01actual

Assets

Drug assets

MK-1167

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
2
Function / daily living
2
Other (unclassified)
2
Safety / tolerability / PK
1
Other clinical outcomes
1

Global cognition

2 endpoints
Primary/protocol endpoint

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

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to approximately 12 weeks

ADAS-Cog

change from baseline, improvement

Function / daily living

2 endpoints
Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and up to approximately 12 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

Time frame:Up to approximately 28 weeks

event count, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

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, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame:Up to approximately 24 weeks

event count, event

Secondary/protocol endpoint/low confidence

ADCS-CGIC Overall Score at Week 12

Time frame:Baseline and up to approximately 12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.