Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
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Purpose
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Drug: Galantamine Drug: Donepezil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Donepezil/ Galantamine in the Treatment of Post-Stroke Cognitively Impaired Rehabilitating Elderly |
- Cognitive and physical function (measured by the Functional Independence Measure and the Apathy Evaluation Scale at Week 12)
- Medication tolerability (measured throughout the study)
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | March 2005 |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Principal Investigator: | Eric J. Lenze, MD | University of Pittsburgh |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00227994 History of Changes |
| Other Study ID Numbers: | K23 MH64196-01, DATR AK-TNGP2 |
| Study First Received: | September 26, 2005 |
| Last Updated: | January 10, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Cholinesterase Inhibitors Elderly Stroke Cognition |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Cholinesterase Inhibitors Galantamine Donepezil |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013