Donepezil Trial for Motor Recovery in Acute Stroke
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|ClinicalTrials.gov Identifier: NCT01442766|
Recruitment Status : Unknown
Verified September 2011 by Imperial College London.
Recruitment status was: Not yet recruiting
First Posted : September 29, 2011
Last Update Posted : September 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Drug: Donepezil Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised-controlled Trial of Donepezil for Motor Recovery in Acute Stroke|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||May 2014|
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.
- Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks [ Time Frame: 12 weeks ]
- Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks [ Time Frame: 12 weeks ]resting-state / activation-related fMRI
- Number and type of participants with adverse events [ Time Frame: 12 weeks ]Self-reported / Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442766
|Contact: Paul Bentley, MA MRCP PhDfirstname.lastname@example.org|
|Charing Cross Hospital, Imperial College Academic Health Science Centre||Not yet recruiting|
|London, United Kingdom, W6 8RF|
|Contact: Paul Bentley, MA MRCP PhD 02033111184 email@example.com|
|Principal Investigator:||Paul Bentley, MA MRCP PhD||Imperial College London|