Traumatic Brain Injury (TBI) Injury, Occupational Diseases, Poisoning Intracranial injury
Conditions
Interventions
Acetylcholinesterase inhibitor ? donepezil versus placebo for six months
Trial details received 12 Sept 2005
Sponsors
Baycrest Centre for Geriatric Care (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Episodic verbal learning and memory measured at six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed