Contact information
Type
Scientific
Primary contact
Dr Robert Van Reekum
ORCID ID
Contact details
Baycrest Centre for Geriatric Care
Department of Psychiatry
3560 Bathurst Street
Room 4W02
Toronto
M6A 2E1
Canada
+1 416 785 2500 X2521
l.ostrander@sympatico.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-58345
Study information
Scientific title
Acronym
Study hypothesis
1. To demonstrate if an acetylcholinesterase inhibitor, donepezil, will improve cognition, affect, behavioural, functional and quality of life outcomes in patients with a history of TBI
2. To identify predictors of positive response to acetylcholinesterase inhibitors in this population
3. To increase understanding of basic neuronal mechanisms underlying human cognition and behaviour
Ethics approval
The joint Baycrest Centre for Geriatric Care/University of Toronto Research Ethics and Scientific Review Committee, Toronto, ON, January 16, 2003
Study design
Randomised placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Traumatic Brain Injury (TBI)
Intervention
Acetylcholinesterase inhibitor donepezil versus placebo for six months
Trial details received 12 Sept 2005
Intervention type
Drug
Phase
Not Specified
Drug names
Donepezil
Primary outcome measures
Episodic verbal learning and memory measured at six months.
Secondary outcome measures
1. Information processing speed at two and six months
2. Attention at two and six months
3. Problem solving at two and six months
4. Behaviour at two and six months
5. Affect at two and six months
6. Daily functioning at two and six months
7. Quality of life at two and six months
Overall trial start date
01/06/2004
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. History of head trauma resulting from contact forces or an acceleration/deceleration event
2. Aged 18 - 55 years, either sex
3. At least 6 months post injury
4. Cognitive complaints or cognitive impairment as assessed by the treating clinician
5. Objective evidence of cognitive impairment in the realm of attention, memory, or executive functioning
6. Outpatient status
7. Able to identify a caregiver
8. Consent granted by subjects NOT deemed incompetent to do so OR consent given by substitute decision maker to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
92
Participant exclusion criteria
1. History of other central nervous system injury or disease (e.g. Alzheimers disease)
2. Relative contradictions for donepezil (including uncontrolled diabetes, current peptic ulcer, glaucoma etc.)
3. History of ongoing alcohol or drug abuse
4. Current Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) axis I diagnosis of schizophrenia, bipolar disorder, or untreated depression
5. Physical or language impediments to completion of the measures
6. Concurrent of benzodiazepines, all antidepressants (with the exception of selective serotonin re-uptake inhibitors [SSRIs], which will be allowed), neuroleptics, and/or anticholinergic medications
7. Persistent post traumatic amnesia, as defined by a Galveston orientation and amnesia test (GOAT) score of 75 or less at the time of study
8. Age <18 or Age >55
9. Not in agreement to use acceptable contraception
10. Performance below 9 on the forced-choice component of the 21 item test
11. Performance of 85 or above (index score) in each construct of the RBANS test
Recruitment start date
01/06/2004
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Baycrest Centre for Geriatric Care
Toronto
M6A 2E1
Canada
Sponsor information
Organisation
Baycrest Centre for Geriatric Care (Canada)
Sponsor details
3560 Bathurst St.
Toronto
M5N 2R4
Canada
+1 416 785 2500
rvanreekum@baycrest.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-58345)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary