Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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. Alzheimer’s 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

Publication citations

Additional files

Editorial Notes