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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

Phase 2 Study of MK-1167 in Participants with Mild to Moderate Alzheimer's Disease Dementia

Masayuki Kobayashi

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Not Recruiting

April. 14, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Alzheimer's Disease Dementia

MK-1167 3 mg qd, MK-1167 1 mg qd, MK-1167 0.3 mg qd or placebo qd will be administered orally for 24 weeks.

- Change from baseline in the ADAS-Cog11 Total Score at Week 24
- Number of participants who experience one or more AEs
- Number of participants who discontinue study intervention due to an AE

- ADCS-CGIC Overall Score at Week 24 and Week 12
- Change from baseline in the ADCS-ADL Total Score at Week 24 and Week 12
- Change from baseline in the ADAS-Cog11 Total Score at Week 12

+81-42-648-5551

Jan. 24, 2025

Yes

https://engagezone.msd.com/wp-content/uploads/sites/518/2024/11/ProcedureAccessClinicalTrialData.pdf

US/Canada/Argentina/ Italy/Netherlands/Spein/UK/Sounth Korea