NCT01893398已完成不适用
Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in behavioral level
研究概览
简要总结
Our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).
The purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by AD in mild to moderate stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of possible/probable AD
- •mild to moderate stage of AD (MMSE score of 15 - 24)and CDR score of 1-2
- •range years in age (65-85) and in school attendance (5-17)
- •right handed
排除标准
- •severe aphasia (Token test score < 20)
- •severe auditory and/or visual loss
- •overt severe behavioral disturbances (delusions, hallucinations, agitation)
- •recent (three month before the MST) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.
结局指标
主要结局
Change from baseline in behavioral level
时间窗: Baseline, 10ws, 22ws
Neuropsychiatric Inventory scale
Change from baseline in cognitive level
时间窗: Baseline, 10ws, 22 ws
ADAS cog scale
Change from baseline in quality of life
时间窗: baseline, 10ws,22 ws
SF36 questionaire
次要结局
未报告次要终点
研究者
研究点 (1)
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