NCT00130338已完成3 期
An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 521
- 主要终点
- Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
研究概览
简要总结
The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.
排除标准
- •Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks
结局指标
主要结局
Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
次要结局
- 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
研究者
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