NCT00196690已完成4 期
Treatment With Donepezil of Chronic Aphasia and Sensorimotor Deficits Associated to Cerebrovascular Accidents: a Double-Blind,Placebo-Controlled, Randomized Parallel Trial.
Gabinete Berthier y Martínez2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Language function (overall aphasia severity)
研究概览
简要总结
- Aphasia (impairment of language function due to brain damage)may be treated with speech-language therapy and drugs. Several drugs have been studied but with limited success.
- Recent data suggest that the neurotransmitter acetylcholine may be reduced in brain damaged subjects and that drugs that stimulates acetylcholine activity may help recovery of aphasic deficits particularly when paired with speech-language therapy.
- Recent evidence indicates that medicaments acting on the neurotransmitter acetylcholine may promote improvement of aphasic deficits and our previous open-label study of donepezil in post-stroke aphasia showed benefits in all patients and observed benefit were long-lasting (6 months).This study will test the safety and efficacy of donepezil (an agent acting on acetylcholine)in subjects with stroke-related chronic aphasia (more than 1 yr of evolution).
详细描述
- Prior clinical information of donepezil treatment of post-stroke aphasia comes from single-case studies, small case-series and an open-label study. In addition, an extension phase of a small open-label study also suggest that the efficacy of donepezil in chronic post-stroke apahsia is maintained at long-term follow-up. These data collectively suggest that in post-stroke donepezil is effective and well-tolerated with a limited potential for causing clinically significant interactions when prescribed with other medications. However, these results are preliminary and should be judged parsimoniously until randomized controlled trials will be performed.Moreover, recent data by our group also showed that donepezil may improve sensorimotor deficits (hemiparesis)in some patients.
- The use of acetylcholinesterase inhibitors such as donepezil in post-stroke may be justified because in vivo and postmortem studies have shown that patients with vascular dementia and lesions in subcortical and cortical structures have deficient cholinergic neurotransmission that results from interruption of cholinergic pathways linking the basal forebrain with the cerebral cortex, including the perisylvian language area.In addition, two large-scale randomized controlled trials in patients pure vascular dementia and vascular cognitive impairment found that donepezil was significantly superior to placebo on cognition, global function and activities of daily living.And the most noticeable benefits of donepezil over placebo at doses of 5-mg and 10-mg were found on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog/11), an assessment instrument highly reliant upon language variables (6 out of 11 items).
- We evaluated the efficacy of donepezil in patients with chronic aphasia associated with stroke.This is a 20-week, randomized, placebo-controlled, double-blind parallel study that enrolled aphasic patient with more than one year of evolution. During the study all patients continued receiving two hours weekly of conventional speech-language therapy. Patients were randomized in an 1:1 ratio to donepezil, 5-mg/day, for the first 4 weeks, followed by forced dose escalation to 10-mg/day thereafter (n =13), or placebo (n = 13) and then a 4 week washout period. The primary efficacy measures were the Aphasia Quotient (AQ) of the Western Aphasia Battery and the Communicative Activity Log. Secondary efficacy measures included selected subtests of the Psycholinguistic Assessment of Language Processing in Aphasia that examined phonological and lexical-semantic domains and the Stroke Aphasia Depression Questionnaire.
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
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic aphasia of more than one year duration. Must be able to complete protocol.
排除标准
- •Heart block
- •Bronchial Asthma
- •Hypersensitivity to donepezil
- •Major psychiatric illness
结局指标
主要结局
Language function (overall aphasia severity)
Communication
次要结局
- Depression
- Cognitive evaluation of language function
研究者
研究点 (2)
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