Phase 4
Completed N=40
Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
Cerebrovascular Accident
Source: ClinicalTrials.gov NCT00227994 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Physical Function (Measured by the FIM-motor) — 47.1; 49.4; 73.1; 87.4 units on a scale
◆ Published Evidence
Established
71citations · ~4 / year
An open-label pilot study of acetylcholinesterase inhibitors to promote functional recovery in elderly cognitively impaired stroke patients.
Summary
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.
Linked Publications
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An open-label pilot study of acetylcholinesterase inhibitors to promote functional recovery in elderly cognitively impaired stroke patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Function (Measured by the FIM-motor) |
47.1; 49.4; 73.1; 87.4 | — |
| SECONDARY Medication Tolerability |
5; 5 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00227994) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.