NCT00348192已完成2 期
A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 27
- 主要终点
- Change in cognition and function after 24 weeks.
研究概览
简要总结
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-
- •Subjects and their caregivers must provide informed consent prior to study entry.
- •Adequate blood pressure and laboratory values.
排除标准
- •Females of child-bearing potential.
- •Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
- •Subjects taking medication for Alzheimers disease or centrally acting agents which might impact study outcomes.
- •Subjects taking agents for which there is a theoretical risk of interaction with SB-742457 or donepezil.
- •Subjects with conditions which might be exacerbated by exposure to donepezil.
- •Subjects with known hypersensitivity to sunlight or seizures.
结局指标
主要结局
Change in cognition and function after 24 weeks.
次要结局
- Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status
研究者
研究点 (27)
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