Donepezil Trial for Motor Recovery in Acute Stroke

This study is not yet open for participant recruitment.
Verified September 2011 by Imperial College London
Sponsor:
Collaborator:
International Stem Cell Forum
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01442766
First received: September 21, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Acute Stroke
Drug: Donepezil
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised-controlled Trial of Donepezil for Motor Recovery in Acute Stroke

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    resting-state / activation-related fMRI

  • Number and type of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Self-reported / Questionnaire


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442766

Contacts
Contact: Paul Bentley, MA MRCP PhD 02033111184 p.bentley@imperial.ac.uk

Locations
United Kingdom
Charing Cross Hospital, Imperial College Academic Health Science Centre Not yet recruiting
London, United Kingdom, W6 8RF
Contact: Paul Bentley, MA MRCP PhD     02033111184     p.bentley@imperial.ac.uk    
Sponsors and Collaborators
Imperial College London
International Stem Cell Forum
Investigators
Principal Investigator: Paul Bentley, MA MRCP PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01442766     History of Changes
Other Study ID Numbers: CRO1793
Study First Received: September 21, 2011
Last Updated: September 29, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
cholinesterase inhibitor
donepezil
motor
stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cholinesterase Inhibitors
Donepezil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013