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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease; Dementia

Treatments: Drug: MK-1167; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06721156

1167-008

jRCT2031240682 (Registry Identifier)

2024-515539-31 (Registry Identifier)

U1111-1309-3391 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 350 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 4 patient groups, including a placebo group

MK-1167 3 mg

Experimental group

Description:

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

Treatment:

Drug: MK-1167

MK-1167 1 mg

Experimental group

Description:

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

Treatment:

Drug: MK-1167

MK-1167 0.3 mg

Experimental group

Description:

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

Treatment:

Drug: MK-1167

Placebo

Placebo Comparator group

Description:

Participants take placebo QD for up to approximately 24 weeks.

Treatment:

Drug: Placebo