The National Institute on Disability and Rehabilitation Research (NIDRR) has awarded $3 million to the TIRR Memorial Hermann hospital to perform a 5-year study to determine whether the medicine donepezil is an effective treatment for memory deficits resulting from traumatic brain injury (TBI).
Memory deficits are among the most common chronic and functionally important consequences of TBI. Donepezil is in a class of medications called acetylcholinesterase inhibitors. It improves memory performance in adults with neurological conditions by increasing the amount of the neurotransmitter acetylcholine in the brain. Entitled “Multicenter Evaluation of Memory Remediation after TBI with Donepezil” (the MEMRI-TBI-D Study), this 10-week 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.
The Principal Investigator/Project Director for the MEMRI-TBI-D Study is David B. Arciniegas, MD, Senior Scientist and Medical Director for Brain Injury Research TIRR Memorial Hermann and Executive Director of the Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry at the Baylor College of Medicine. Angelle Sander, PhD, Senior Scientist and Director of the Brain Injury Research Center at TIRR Memorial Hermann, and Associate Professor of Physical Medicine and Rehabilitation with Baylor College of Medicine, will serve as Co-Principal Investigator. Drs. Arciniegas and Sander are joined by Co-Investigator Mark Sherer, PhD, Senior Scientist, Director of Research at TIRR Memorial Hermann and Clinical Professor of Physical Medicine and Rehabilitation at the Baylor College of Medicine and the University of Texas Medical School at Houston. As the recipient of the grant, TIRR Memorial Hermann will lead a national team of collaborators at Spaulding Rehabilitation Hospital (Boston, MA), Moss Rehabilitation Research Institute (Philadelphia, PA), Indiana University (Indianapolis, IN), and Craig Hospital (Englewood, Colorado).
“We’re fortunate to bring this group of investigators together to perform this clinical trial,” said Dr. Arciniegas. “The MEMRI-TBI-D Study capitalizes on the extensive successful research on brain injury rehabilitation within and between the participating centers. It also will benefit from this groups’ expertise in the study of pharmacologic and rehabilitative treatments for cognitive problems resulting from traumatic brain injuries.”
The Brain Injury Research center at TIRR was founded in the 1980s and conducts research that improves outcomes for persons with brain injuries. The principal goal of this research is to reduce barriers to everyday function and to enable persons with brain injury to return to full participation in life.
Dr. Arciniegas said, “The goal of this study is to use donepezil, a medicine that addresses one of the chronic neurochemical deficits produced by traumatic brain injury, to improve memory performance in persons with TBI. If this treatment is successful, persons with memory problems after TBI will be experience improvements in day-to-day memory and be able to participate more fully and independently at home and in the community.”
The MEMRI-TBI-D Study is a four site, randomized, parallel design, double blind, placebo controlled, 10-week trial that will evaluate the effect of donepezil on treatment for functionally important verbal memory problems among 160 individuals (age 18-60 years) who sustained a complicated mild, moderate, or severe non-penetrating TBI six to 36 months prior to study participation. Enrollment will begin in the Spring of 2014. Each site will enroll 10 participants per year over the 48-month period of active recruitment.
The announcement of the grant comes right on the opening of TIRR Memorial Hermann’s new Research Center, in which Drs. Arciniegas, Sander, and Sherer will office. “The design of the new center will make a big contribution to the quality of the science we can carry out and the ease of collaboration between our group and our collaborators,” said Dr. Mark Sherer.
If the MEMRI-TBI-D Study demonstrates that donepezil improves memory performance among persons with TBI, the quality of the evidence yielded by this study will directly affect the way healthcare providers serve persons with memory problems after TBI. 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. “If donepezil is found to be effective in individuals with memory problems after TBI, we hope that these findings will inform the practices of rehabilitation programs across the country and internationally," said Dr. Arciniegas.