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

Phase 2TerminatedNCT06721156

Merck Sharp & Dohme LLC369 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

369

Conditions

Alzheimer Disease Dementia

Interventions

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to approximately 28 weeks

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 24 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and up to approximately 12 weeks