NCT00130429已完成2 期
Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type
Phytopharm2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Hopkins verbal learning test (revised) total word recall after 12 weeks
研究概览
简要总结
The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.
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
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
- •At least 50 years of age
- •Diagnosis of possible or probable Alzheimer's disease
- •Mini mental state examination score at least 16
- •Good understanding of both written and verbal English
- •A recent head scan that is consistent with the diagnosis of Alzheimer's disease
排除标准
- •Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
- •Known to have another condition that is associated with dementia
- •Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
- •Hormone replacement therapy started or changed within the previous 6 months
- •Received any investigational drugs within the previous 12 weeks
结局指标
主要结局
Hopkins verbal learning test (revised) total word recall after 12 weeks
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
次要结局
- Mini mental state examination score
- Clinical dementia rating (overall and sum of boxes)
- CANTAB rapid visual information processing (RVIP) mean latency
- CANTAB RVIP total correct hits
- CANTAB spatial working memory within error, between error and strategy scores
- Clinicians global impression of change
- Disability assessment for dementia score
研究者
研究点 (2)
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