A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
研究概览
简要总结
This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ambulatory, male or female and 55 years of age or older
- •Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel
排除标准
- •Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
- •Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes
研究组 & 干预措施
Donepezil 5-10 mg
There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
干预措施: Donepezil 5 - 10 mg (Drug)
Donepezil 5-10 mg
There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
干预措施: Donepezil 10 mg (Drug)
Placebo
There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.
干预措施: Donepezil 10 mg (Drug)
结局指标
主要结局
Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
时间窗: Baseline and 4 weeks
CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.
次要结局
- Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12(Baseline and 2 weeks, 8 weeks and 12 weeks)
- Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12(Baseline and 4 weeks, 8 weeks and 12 weeks.)