NCT00134953终止3 期
Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 24
- 主要终点
- 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
研究概览
简要总结
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).
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
- •Males or females who are one year post-menopausal or without childbearing potential
- •Between the ages of 50 and 85 years old
- •Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27
- •Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement
排除标准
- •A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia
- •A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication
- •An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
次要结局
- Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
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