A Randomised Controlled Trial of the effects of donepezil on cognitive, behavioural, and functional outcome in traumatic brain injury
| ISRCTN | ISRCTN16354639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16354639 |
| Secondary identifying numbers | MCT-58345 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 17/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Van Reekum
Scientific
Scientific
Baycrest Centre for Geriatric Care
Department of Psychiatry
3560 Bathurst Street, Room 4W02
Toronto
M6A 2E1
Canada
| Phone | +1 416 785 2500 X2521 |
|---|---|
| l.ostrander@sympatico.ca |
Study information
| Study design | Randomised placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | The joint Baycrest Centre for Geriatric Care/University of Toronto Research Ethics and Scientific Review Committee, Toronto, ON, January 16, 2003 |
| Health condition(s) or problem(s) studied | Traumatic Brain Injury (TBI) |
| Intervention | Acetylcholinesterase inhibitor donepezil versus placebo for six months Trial details received 12 Sept 2005 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Donepezil |
| Primary outcome measure | 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 study start date | 01/06/2004 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 92 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Baycrest Centre for Geriatric Care
Toronto
M6A 2E1
Canada
M6A 2E1
Canada
Sponsor information
Baycrest Centre for Geriatric Care (Canada)
Hospital/treatment centre
Hospital/treatment centre
3560 Bathurst St.
Toronto
M5N 2R4
Canada
| Phone | +1 416 785 2500 |
|---|---|
| rvanreekum@baycrest.org | |
"ROR" |
https://ror.org/03gp5b411 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-58345)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
