NCT01633593终止4 期
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- reduction of the duration of delirium in elderly patients treated with donepezil
研究概览
简要总结
Nowadays features for the diagnosis of delirium are:
- Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;
- A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;
- The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;
- There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.
Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.
The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 60 year old
- •Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit)
- •informed consent (legal representatives)
排除标准
- •unable to swallow pills
- •previous allergy to donepezil
- •Atrioventricular block of 2nd and 3nd degree
研究组 & 干预措施
donepezil
Experimental
Donepezil 5mg/day during 2 weeks
干预措施: Donepezil (Drug)
placebo
Placebo Comparator
placebo comparator to donepezil (double blind)
干预措施: Donepezil (Drug)
结局指标
主要结局
reduction of the duration of delirium in elderly patients treated with donepezil
时间窗: 2 weeks
次要结局
- Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil(2 weeks)
研究者
Mario R. Louza, MD, PhD
MD, PhD
University of Sao Paulo
研究点 (1)
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