NCT01143350终止不适用
Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
研究概览
简要总结
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.
- Primary efficacy criteria: Apathy Inventory clinician score changes
- Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 65 years
- •A diagnosis of dementia according to the ICD 10 criteria
- •MMSE score ≤ 24
- •Presenting the diagnostic criteria of apathy (cf page ??)
- •An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)
排除标准
- •Patients more than 65 years
- •MMSE score > 24
结局指标
主要结局
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
时间窗: 1 year
Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
次要结局
- Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes(1 year)
研究者
研究点 (2)
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