Multi-Center Evaluation of Memory Remediation after TBI with Donepezil (MEMRI-TBI-D)

Multi-Center Evaluation of Memory Remediation after TBI with Donepezil (MEMRI-TBI-D)

Department of Health and Human Services
National Institute on Disability, Independent Living, and Rehabilitation Research

Memory deficits are among the most common chronic and functionally important consequences of TBI. Research studies performed over the last 20 years suggest that memory problems after TBI are the result of a change in the amount of a chemical in the brain, acetylcholine, that helps people learn and remember information. Donepezil, an acetylcholinesterase inhibiting medication, improves memory performance in adults with neurological conditions by increasing the amount of the neurotransmitter acetylcholine in the brain. This trial will study the effects of donepezil 10 mg daily on verbal memory problems among adults with TBI in the subacute or chronic recovery period. MEMRI-TBI aspires to become the definitive study addressing the question of whether donepezil is effective in treating posttraumatic memory deficits.

This four site, randomized, parallel design, double blind, placebo controlled, 10-week trial study aims to evaluate the effect of donepezil as treatment for functionally important verbal memory impairments. 160 individuals (age 18-60 years) who sustained a complicated mild, moderate, or severe non-penetrating TBI more than 6 months prior to study participation will be enrolled. The Texas Institute for Rehabilitation Research leads the study, with Indiana University and Moss Rehabilitation serving as sites along with Spaulding. Each site will recruit 10 participants per year over the 48-month period of active enrollment.

If the MEMRI-TBI-D Study demonstrates that donepezil advances memory performance among persons with TBI, the quality of life among these individuals and their families will improve. Information regarding the efficacy and safety of donepezil on functionally important verbal memory deficits, other cognitive and neuropsychiatric symptoms, functional performance, and community participation will directly affect the way healthcare providers serve persons with memory problems after TBI. This study will provide urgently needed information regarding pharmacological treatment of posttraumatic memory deficits in this population and bridge gaps in the current evidence base regarding such treatments. Since donepezil is available in a generic form, it also offers promise of becoming a treatment option that is affordable to many persons with TBI and their families.