A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
研究概览
简要总结
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).
详细描述
The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
- •Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
- •Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.
排除标准
- •Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
- •Current major depressive disorder or other current major psychiatric disorder.
- •History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
- •Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
SAM-531 1.5 mg
干预措施: SAM-531 1.5 mg (Drug)
3
SAM-531 3.0 mg
干预措施: SAM-531 3.0 mg (Drug)
4
SAM-531 5.0 mg
干预措施: SAM-531 5.0 mg (Drug)
5
Donepezil
干预措施: Donepezil (Drug)
结局指标
主要结局
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
时间窗: Baseline, Week 24
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
次要结局
- Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24(Baseline, Week 24)
- Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24(Baseline, Week 24)
- Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24(Baseline, Week 24)
- Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB SWM Strategy at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB PRM-Percentage Correct at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB RTI Simple Movement Time at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24(Baseline, Week 24)
- Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24(Baseline, Week 24)
- Percentage of Participants Who Were Responders at Week 24(Week 24)