NCT00165724已完成4 期
Alzheimer's Disease Long-term Follow-up Study (ALF Study)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 7
- 主要终点
- ADAS-cog
研究概览
简要总结
Open study for efficacy and safety of donepezil treatment during 48 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 40 to 90
- •Diagnosis of dementia according to DSM-IV
- •Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
- •Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
- •Patients were generally healthy and ambulatory or ambulatory aided
- •Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
- •Patients have useful MRI results 3 months before screening
- •If they have evidence of TIA or major infarction
- •Epilepsy patients
- •If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
- •If they sensitive to acetylcholinesterase
- •If they taken concomitant medication which were not allowed
排除标准
- 未提供
结局指标
主要结局
ADAS-cog
次要结局
- MMSE, CDR, GDS, NPI, ADL, SSDQ
研究者
研究点 (7)
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