Donepezil Trial for Motor Recovery in Acute Stroke
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|ClinicalTrials.gov Identifier: NCT01442766|
Recruitment Status : Terminated (No financial support)
First Posted : September 29, 2011
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Drug: Donepezil Drug: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 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|
|Actual Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2013|
|Actual 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
|Charing Cross Hospital, Imperial College Academic Health Science Centre|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Paul Bentley, MA MRCP PhD||Imperial College London|