An increasingly popular medication that slows memory decline in some people with Alzheimer's disease is now being tested in patients with traumatic brain injury.
The University of Florida is one of 15 centers participating in a clinical trial of donepezil, more commonly known by the trade name Aricept. This is the first randomized clinical trial ever conducted to treat lasting effects of traumatic brain injury.
"Because patients with these injuries often have problems with memory and other faculties of cognitive function, the idea is to see whether they're going to benefit as the patients with Alzheimer's did," said the UF study's principal investigator, Basim M. Uthman, M.D., an associate professor in the College of Medicine's departments of neurology and neuroscience and assistant chief of neurology for the Malcom Randall Veterans Affairs Medical Center in Gainesville.
At UF-affiliated hospitals including Shands at UF and the VA medical center, 10 people with mild to moderate memory impairments will be enrolled in the 12-week trial, funded by donepezil manufacturer Eisai Co. Ltd. Participants must be between 18 and 55 and have incurred the injury within the past one to three years. They will be assigned randomly to one of three groups to receive either a placebo, or 5 or 10 milligram daily doses of donepezil. Neither participants or investigators will know who is assigned to which group.
At the start of the study and then at four-week intervals, participants will be given a battery of tests to determine the medication's effects on memory and other mental functions.
UF's clinical trial was approved by the Food and Drug Administration, the university's Institutional Review Board and the VA's Subcommittee for Clinical Investigation.
Ronald L. Hayes, Ph.D., director of the Center for Traumatic Brain Injury Studies at the Evelyn F. and William L. McKnight Brain Institute of UF, said the research is particularly important because there are no proven therapies for traumatic brain injury. Such injuries are the cause of lasting disability in more than 5 million Americans.
"People with traumatic brain injury are at the mercy of any assertion somebody makes that one treatment is better than another," said Hayes, who is the study's co-principal investigator. "But the only real way to demonstrate that a therapy works or not is by doing a clinical trial, and this study is the first randomized clinical trial ever conducted to treat chronic traumatic brain injury.
"Moreover, many people do not know that such injuries can significantly increase their risk for Alzheimer's disease later in life. Effective treatment could ultimately reduce this risk."
The FDA approved the marketing of donepezil for Alzheimer's in 1996. It works by increasing levels of a brain chemical -- acetylcholine -- thought to be important to the brain's processing of memory.
In the mid-1980s, Hayes and colleagues in his laboratory, then located at the Medical College of Virginia, were the first to identify acetylcholine's role in traumatic brain injury.
They discovered that soon after brain injury, toxic levels of the chemical were released, ultimately damaging the brain's ability to produce a sufficient supply of the chemical. - By Victoria White
[Contact: Victoria White]
01-Aug-2001
