A NIDRR Disability Rehabilitation Research Projects (DRRP) Traumatic Brain Injury Model Systems Centers Collaborative Research Project
National PI/PD: David B. Arciniegas, MD (TIRR Memorial Hermann) National Co-‐PI: Angelle Sander, PhD (TIRR Memorial Hermann)
Co-‐Investigators: Mark Sherer, PhD (TIRR Memorial Hermann), Ross D. Zafonte, DO and Joseph Giacino, PhD
(Spaulding Rehabilitation Hospital), Tessa Hart, PhD and John Whyte, MD, PhD (Moss Rehabilitation Research Institute),
Flora Hammond, MD and James Malec, PhD (Indiana University), and Cindy Harrison-‐Felix, PhD (Craig Hospital)
Project Staff: Jay Bogaards, MA and Liu (Eunice) Yang, MS, (TIRR Memorial Hermann), Laura Burns, MBA
(Spaulding Rehabilitation Hospital), Caron Morita, BA (Moss Rehabilitation Research Institute), Christy Sargent, BA
(Indiana University), David Mellick, MA (Craig Hospital), Kara Keuthan Beatty,
MD (Consumer Consultant), Naomi Lynn Gerber, MD (MSKTC)
ABSTRACT
Memory deficits are among the most common chronic and functionally important consequences of traumatic brain injury (TBI).
Basic and clinical research studies suggest that persistent deficits in verbal memory are associated with chronically reduced
levels of acetylcholine in the brain. Medicines that increase levels of acetylcholine in the brain appear to improve memory
and other cognitive problems experienced by persons with TBI. However, the studies performed thus far do not provide the level
of evidence needed to establish best practices. This proposed study will definitively establish whether, and to what extent,
donepezil is an effective treatment for functionally important TBI-related memory deficit. Entitled “Multicenter Evaluation of
Memory Remediation after TBI with Donepezil” (MEMRI-TBI-D Study), the project is a four-site, randomized, parallel design,
double-blind, placebo-controlled, 10-week trial of donepezil 10 mg daily for verbal memory problems among adults with TBI
in the subacute or chronic recovery period. The study will recruit 160 persons with TBI and functionally important memory
problems during a four-year period of open recruitment. The study aims to evaluate the effects of treatment with donepezil
on verbal memory as assessed by the Hopkins Verbal Learning Test-Revised Total Trial 1-3. The study concurrently aims to
evaluate the effects of treatment with donepezil on memory-related activities as measured by the Everyday Memory Questionnaire.
Data will be acquired with which to assess the effects of donepezil on attention, processing speed, neuropsychiatric symptoms,
community participation, quality of life, and caregiver experiences. Findings from this study will influence the practices of
prescribing healthcare providers and contribute information that will improve lives of persons with TBI and their families. In
addition to dissemination of final study results, the MEMRI-TBI- D Study team will disseminate information on evidence-based
treatments for memory impairment to consumer and professional audiences throughout the funding period. Through these knowledge
translation activities we empower consumers to access the most effective interventions for memory impairment, and facilitate
provision of effective interventions by rehabilitation care providers.