Donepezil Trial for Motor Recovery in Acute Stroke

NCT ID: NCT01442766

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Donepezil

Group Type: EXPERIMENTAL

Donepezil

Intervention Type: DRUG

5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.

Interventions

Donepezil

5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue

Intervention Type: DRUG

Placebo

Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.

Intervention Type: DRUG

Other Intervention Names

Aricept

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Stem Cell Forum

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Bentley, MA MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Charing Cross Hospital, Imperial College Academic Health Science Centre

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CRO1793

Identifier Type: -

Identifier Source: org_study_id