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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
Sponsor:
Collaborator:
International Stem Cell Forum
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Acute Stroke Drug: Donepezil Drug: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donepezil Drug: Donepezil
5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue
Other Name: Aricept

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




Primary Outcome Measures :
  1. Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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

  2. Number and type of participants with adverse events [ Time Frame: 12 weeks ]
    Self-reported / Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Charing Cross Hospital, Imperial College Academic Health Science Centre
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
International Stem Cell Forum
Investigators
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Principal Investigator: Paul Bentley, MA MRCP PhD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01442766     History of Changes
Other Study ID Numbers: CRO1793
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
cholinesterase inhibitor
donepezil
motor
stroke
Additional relevant MeSH terms:
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Donepezil
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents