The National Institute on Disability and Rehabilitation Research (NIDRR) has awarded $3 million to TIRR Memorial Hermann to perform a five-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. Basic science studies and clinical trials suggest that persistent deficits in verbal memory are associated with chronically reduced levels of the neurotransmitter acetylcholine in the brain. While medications, such as donepezil, that increase the amount of acetylcholine in the brain appear to improve memory and other cognitive problems, research conducted to date has not provided the level of evidence needed to establish best practices. Investigators at TIRR Memorial Hermann hope evidence gained from the new trial will influence the practices of prescribing healthcare providers and contribute knowledge that will improve the lives of persons with TBI and their families.
Entitled “Multicenter Evaluation of Memory Remediation after TBI with Donepezil” (the MEMRI-TBI-D Study), the 10-week trial will evaluate the effects of 10 milligrams of donepezil, administered daily, on verbal memory problems among adults with TBI in the subacute or chronic recovery period. The study will enroll 160 persons with TBI and functionally important memory problems at four study sites across the country during the four-year period of open enrollment.
Principal investigator/project director for the MEMRI-TBI-D Study is David B. Arciniegas, MD, senior scientist and medical director for brain injury research at TIRR Memorial Hermann and executive director of the Beth K. and Stuart C. Yudofsky division of Neuropsychiatry at Baylor College of Medicine. Neuropsychologist Angelle Sander, PhD, director of the Brain Injury Research Center at TIRR Memorial Hermann and associate professor of physical medicine and rehabilitation at Baylor, is co-principal investigator. Dr. Arciniegas and Dr. Sander are joined by co-investigator Mark Sherer, PhD, ABPP, FACRM, director of research and director of neuropsychology at TIRR Memorial Hermann and clinical professor of physical medicine and rehabilitation at Baylor College of Medicine. As the recipient of the grant, TIRR Memorial Hermann will lead a national team of collaborators at Spaulding Rehabilitation Hospital in Boston, Moss Rehabilitation Research Institute in Philadelphia, Indiana University in Indianapolis and Craig Hospital in Englewood, Colo.
“We’re fortunate to bring this group of investigators together to conduct this clinical trial,” Dr. Arciniegas says. “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 announcement of the grant coincides with the opening of the TIRR Memorial Hermann Research Center, the new home of the Brain Injury Research Center (BIRC). BIRC was founded in the 1980s to conduct research that improves outcomes for persons with brain injuries. The principal goal of research conducted at the Center is to reduce barriers to daily function and enable persons with brain injury to return to full participation in life. “The design of the new center is making an enormous contribution to the quality of science we can carry out and the ease of collaboration between our group and our collaborators,” Dr. Sherer says.
If this treatment is successful, persons with memory problems after TBI will experience improvements in day-to-day memory.
The goals of the MEMRI-TBI-D Study complement those of other research projects under way at BIRC. “Our aim is to determine if donepezil, a medicine that addresses one of the chronic neurochemical deficits produced by traumatic brain injury, improves memory performance in persons with TBI,” Dr. Arciniegas says. “If this treatment is successful, persons with memory problems after TBI will experience improvements in day-to-day memory.”
Enrollment will begin in spring 2014; each study site will enroll 10 participants per year over the 48-month period of active recruitment. “The quality of the evidence yielded by this study will directly affect the way healthcare providers serve persons with memory problems after TBI,” Dr. Arciniegas says. “Since donepezil is available in a generic form, it also offers the promise of an affordable treatment option for 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.”