Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke

Phase 4

Completed

Conditions: Cerebrovascular Accident

Interventions: Drug: Donepezil
Drug: Galantamine

Registration Number: NCT00227994

Lead Sponsor: University of Pittsburgh

Brief Summary: This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donepezil	Donepezil	Donepezil for 12 weeks
Galantamine	Galantamine	Galantamine for 12 weeks

Primary Outcome Measures

Name	Time	Method
Physical Function (Measured by the FIM-motor)	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

Secondary Outcome Measures