Donepezil/ Galantamine in the Treatment of Post-stroke Cognitively Impaired Rehabilitating Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Physical Function (Measured by the FIM-motor)
研究概览
简要总结
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.
详细描述
Cognitive impairment is a common result of a stroke and can be detrimental to recovery. It can negatively affect both mental and physical functioning, thereby complicating the rehabilitation process. Although much research has targeted the effects of long-term cognitive impairment after a stroke, very little research has been done to examine the incidence and course of cognitive impairment during the first three months following a stroke. These first three months are the most important in terms of regaining function. Acetylcholinesterase inhibitors have been beneficial to both sufferers of vascular dementia and Alzheimer's disease. They may also be a useful pharmacologic intervention to enhance post-stroke rehabilitation. This study will compare the effectiveness of two acetylcholinesterase inhibitors, galantamine and donepezil, in improving cognitive function and overall rehabilitation in elderly stroke survivors.
Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks. Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks. Functional independence will be measured at baseline and Weeks 2 and 12. In addition, a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families. Participants will also be monitored for signs of depression and medication side effects throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke (cardiovascular accident)
- •Stroke was within 30 days of being admitted
- •Medically stable
- •Presence of memory and/or attentional impairments and evidence that these impairments were not present or were less severe prior to the stroke (assessed via interview with family)
- •Approval by individual's attending physician at the rehabilitation hospital
排除标准
- •Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid neuropsychiatric assessment
- •Currently experiencing a major depressive episode (unless treated and in partial remission, assessed using the Primary Care Evaluation of Mental Disorders)
- •Current psychosis or mania
- •History of substance or alcohol abuse or dependence within three months of study entry
- •Currently taking a cholinomimetic drug
- •Medical condition with known sensitivity to donepezil (e.g., slower than normal heart rate, supraventricular cardiac conduction defects, severe asthma or obstructive pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if not on acid-blocking agent)
- •Informed that taking donepezil is medically inadvisable
- •Current use of any anticholinergic medication (e.g., for bladder spasm)
研究组 & 干预措施
Galantamine
Galantamine for 12 weeks
干预措施: Galantamine (Drug)
Donepezil
Donepezil for 12 weeks
干预措施: Donepezil (Drug)
结局指标
主要结局
Physical Function (Measured by the FIM-motor)
时间窗: Measured at weeks 0 and 12
Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence
次要结局
- Medication Tolerability(Measured throughout the study)
研究者
Eric Lenze
Professor of Psychiatry
University of Pittsburgh