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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 369
- 试验地点
- 144
- 主要终点
- Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Participants take placebo QD for up to approximately 24 weeks.
干预措施: Placebo (Drug)
MK-1167 3 mg
Participants receive 3 mg of MK-1167 once daily (QD) for up to approximately 24 weeks.
干预措施: MK-1167 (Drug)
MK-1167 1 mg
Participants receive 1 mg of MK-1167 QD for up to approximately 24 weeks.
干预措施: MK-1167 (Drug)
MK-1167 0.3 mg
Participants take 0.3 mg of MK-1167 QD for up to approximately 24 weeks.
干预措施: MK-1167 (Drug)
结局指标
主要结局
Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24
时间窗: Baseline and up to approximately 24 weeks
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.
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to approximately 28 weeks
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.
Number of Participants Who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 24 weeks
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.
次要结局
- Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24(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(Baseline and up to approximately 24 weeks)
- Change From Baseline in the ADAS-Cog11 Total Score at Week 12(Baseline and up to approximately 12 weeks)
- ADCS-CGIC Overall Score at Week 12(Baseline and up to approximately 12 weeks)
- Change From Baseline in the ADCS-ADL Total Score at Week 12(Baseline and up to approximately 12 weeks)