The University of Rochester School of Medicine and the University of Nebraska Medical Center collaborated on the pilot study, which was funded by the National Institute of Mental Health.
The study involved 22 patients with HIV-related dementia, 16 with cognitive impairment, six without. Patients were randomized to receive either 250 milligrams of valproic acid, or placebo, twice daily. Valproic acid is commonly used to prevent seizures in epilepsy patients.
"This shows that a common, inexpensive drug gets into the brain, and may, in fact, have a real benefit in restoring cognitive function in patients with HIV-related dementia, and perhaps other neuro-inflammatory diseases such as Alzheimer's," said Harris Gelbard, M.D., professor of neurology at the University of Rochester Medical Center and the study's principal investigator.
The clinical trial results help prove a theory developed four years ago at UNMC.
"We began studying the molecules and proteins inside the nerve cell to find out whether this class of drug could change how the nerve cell functions and protect it from injury and death in a toxic inflammatory environment," said Howard Gendelman, M.D., director for the Center of Neurovirology and Neurodegenerative Disorders at UNMC.
Initial results from Dr. Gendelman's cell studies led to animal studies, where proof-of-concept was realized, and finally to the Phase I clinical trial in humans.
"We're very excited by what we found," said Dr. Gendelman, who is also professor and chairman of the Department of Pharmacology and Experimental Neuroscience. "Most importantly, the neuroprotection from valproic acid we found in pat
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Contact: Michael Wentzel
Michael_Wentzel@urmc.rochester.edu
585-275-1309
University of Rochester Medical Center
13-Mar-2006