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

This study has been completed.
Study NCT00227994.   Last updated on January 10, 2006.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
Official Title  Donepezil/ Galantamine in the Treatment of Post-Stroke Cognitively Impaired Rehabilitating Elderly
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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Cognitive and physical function (measured by the Functional Independence Measure and the Apathy Evaluation Scale at Week 12)
Secondary Outcome Measure  Medication tolerability (measured throughout the study)
Condition  Cerebrovascular Accident
Intervention  Drug: Galantamine
Drug: Donepezil
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  40
Start Date  April 2003
Completion Date March 2005
Eligibility Criteria 

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)
Gender Both
Ages 60 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00227994
Organization ID K23 MH64196-01
Secondary IDs †† DATR AK-TNGP2
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Eric J. Lenze, MD     University of Pittsburgh    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date January 2006
First Received Date  September 26, 2005
Last Updated Date January 10, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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