NCT00522015Unknown2 期
Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
研究概览
简要总结
to show that
- patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function
- use of rivastigmine has a positive effect on apathy in PSP patients
- therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST
- changes in motor activity are associated with changes in language and overall results of the in MMST
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PSP
- •willingness to participate in the study
- •informed consent
- •ability to speak
- •no further CNS diseases
- •written informed consent
- •stable state of health
- •ability to give informed consent, will checked by an independent physician
排除标准
- •alcohol abuses
- •acute psychosis
- •pregnancy or lactation
- •known previous drug reaction or hypersensitivity of rivastigmine or other carbamate derivatives
- •liver failure
- •known sick sinus syndrome or excitation disturbance
- •known ulcus ventriculi or duodenal ulcer
- •known asthma or COPD
- •renal failure
研究组 & 干预措施
1
Active Comparator
patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
干预措施: rivastigmine (Drug)
结局指标
主要结局
improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
时间窗: 6 month
次要结局
- changes in speech function and improvement of quality of life(6 Month)
研究者
研究点 (1)
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