Donepezil Trial for Motor Recovery in Acute Stroke
Stroke is a major personal and social burden, being the commonest cause of severe adult disability. Recovery has been shown in animal models to be dependent upon adequate levels of acetylcholine within the brain - which in stroke is likely to be deficient. This is because acetylcholine-producing nerve cells in the brain are often damaged by strokes. Consequently, the investigators hypothesise that recovery may be improved by boosting acetylcholine levels in the brain - that can be readily achieved by treating with donepezil.
AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients taking donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes as a result of donepezil after 12 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised-controlled Trial of Donepezil for Motor Recovery in Acute Stroke|
- Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]resting-state / activation-related fMRI
- Number and type of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Self-reported / Questionnaire
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue
Other Name: Aricept
|Placebo Comparator: Placebo||
Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.
|Contact: Paul Bentley, MA MRCP PhDemail@example.com|
|Charing Cross Hospital, Imperial College Academic Health Science Centre||Not yet recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Paul Bentley, MA MRCP PhD 02033111184 firstname.lastname@example.org|
|Principal Investigator:||Paul Bentley, MA MRCP PhD||Imperial College London|