Cerebrovascular Accident Clinical Trial
Official title:
Donepezil/ Galantamine in the Treatment of Post-stroke Cognitively Impaired Rehabilitating Elderly
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.
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.
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