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Donepezil Trial for Motor Recovery in Acute Stroke

Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Stroke

Intervention: Donepezil (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Paul Bentley, MA MRCP PhD, Principal Investigator, Affiliation: Imperial College London

Overall contact:
Paul Bentley, MA MRCP PhD, Phone: 02033111184, Email: p.bentley@imperial.ac.uk

Summary

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.

Clinical Details

Official title: A Randomised-controlled Trial of Donepezil for Motor Recovery in Acute Stroke

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks

Secondary outcome:

Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks

Number and type of participants with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients diagnosed with acute stroke diagnosed on clinical and neuroimaging grounds who can enter the trial within the 1st week of stroke onset, and who have new motor

dysfunction of an upper limb. Motor impairment should be moderate - severe (UE-FM

Score ≤50 out of a total of 66). 2. Age: above 18 years old. 3. Patients able and willing to partake in motor tests, and to return for follow-up visit at 12 weeks. 4. Able to understand English. Exclusion Criteria: 1. Contraindications for donepezil: pregnancy (* Female patients <50 years old will be asked if there is any possibility that they might be pregnant. If there is any uncertainty, or a likelihood that they are pregnant, this will qualify as an

exclusion criterion)*; moderate - severe asthma (i. e. regular treatment prescribed

for this); bradycardia, syncope, 2nd or 3rd degree heart block, acute or decompensated heart failure; peptic ulcer diagnosed endoscopically and on treatment for this; epilepsy; Parkinson's disease; end-stage renal failure or creatinine > 300 micromol/l; genitourinary tract or gastrointestinal tract obstruction; gastrointestinal tract hemorrhage; myasthenia gravis 2. Other: functionally-significant cognitive impairment (i. e. dementia); significant receptive aphasia (i. e. such that cannot understand purpose or details of trial, and will be unable to cooperate with task instructions); significant physical infirmity as judged by treating physician (e. g. severe organ failure; terminal cancer). 3. Contraindications for MRI (this only pertains for the subset of patients entering the MRI substudy, but is not a contra-indication to the main study providing a diagnosis of stroke is clear from CT): phobia, metal implants including pacemaker.

Locations and Contacts

Paul Bentley, MA MRCP PhD, Phone: 02033111184, Email: p.bentley@imperial.ac.uk

Charing Cross Hospital, Imperial College Academic Health Science Centre, London W6 8RF, United Kingdom; Not yet recruiting
Paul Bentley, MA MRCP PhD, Phone: 02033111184, Email: p.bentley@imperial.ac.uk
Additional Information

Starting date: November 2011
Last updated: September 29, 2011

Page last updated: August 23, 2015

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