A Randomized, Double-Blinded Study to Evaluate the Efficacy and Safety of Mevidalen in Patients With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 119
- 主要终点
- Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
研究概览
简要总结
The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living.
- •Have MMSE score of 13 to
- •Have eligibile plasma P-tau or historical evidence of AD pathology.
- •Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times.
- •Males with partners of childbearing potential must agree to abide with provided contraception guidance.
排除标准
- •Are individuals of childbearing potential.
- •Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.,).
- •Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.
- •Use of moderate or strong CYP3A4 inhibitors or inducers.
- •Have participated within the last 30 days in a clinical trial involving an investigational product.
- •Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
研究组 & 干预措施
Mevidalen (high dose)
Mevidalen high dose administered orally.
干预措施: Mevidalen (Drug)
Mevidalen (low dose)
Mevidalen low dose administered orally.
干预措施: Mevidalen (Drug)
Placebo
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
时间窗: Baseline, Week 24
iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.
次要结局
- Change from Baseline in Mini Mental State Examination (MMSE)(Baseline, Week 24)
- Change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)(Baseline, Week 24)
- Change from Baseline on Epworth Sleepiness Scale (ESS)(Baseline, Week 24)
- Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)(Baseline, Week 24)
- Change from Baseline in Digit Symbol Coding Test( Wechsler Adult Intelligence Scale-IV)(WAIS-IV)(Baseline, Week 24)
- Change from Baseline in Verbal Fluency Test(Baseline, Week 24)
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score (ADCS-CGIC)(Week 24)
- Change from Baseline on Neuropsychiatric Inventory (NPI-12)(Baseline, Week 24)
- Change from Baseline in Category Fluency Test(Baseline, Week 24)
- Change from Baseline on Quick Dementia Rating Scale (QDRS)(Baseline, Week 24)