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Creatine tested for Parkinson's therapy MUSC researchers will help lead a national study investigating the effectiveness of the nutritional supplement creatine in slowing the progression of Parkinson’s disease (PD).   The National Institute of Neurological Disorders and Stroke (NINDS) announced March 21 its third phase of a large-scale clinical trial, which will be led by Barbara C. Tilley, Ph.D., of MUSC; and Karl Kieburtz, M.D., of the University of Rochester in New York. Patients will be seen by movement disorders specialists at sites across the United States and Canada.   Kenneth Bergmann, M.D., associate professor, Department of Neurosciences, and director of the Murray Center for Research on Parkinson's Disease and related Disorders, is principal investigator of the MUSC clinical site where patients will be seen for the trial.   “It is of critical importance that every patient with Parkinson's disease participate in treatment trials, especially in the earliest stages of illness,” said Bergmann. “Just as they have in cancer research, these trials create incremental changes in treatment. Over time these add up to a significantly longer life and a life of better quality.”   As principal investigator of the Statistical Center, Tilley  and her group have played a central role in the design of this new trial and in the management of smaller, related studies.   While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds.   The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1,720 people with early-stage PD at 52 medical centers in the United States and Canada.   “This study is an important step toward developing a therapy that could change the course of this devastating disease,” said Elias A. Zerhouni, M.D., director of the National Institutes of Health. “The goal is to improve the quality of life for people with Parkinson’s for a longer period of time than is possible with existing therapies.”   To date, no treatment has been shown to slow the progression of PD.   The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson’s disease). NINDS has organized this large network of sites to allow researchers to work with PD patients during a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process—from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinson’s disease.   “NET-PD has provided the opportunity to work with outstanding investigators from across North America to design an innovative  treatment  trial for Parkinson’s disease,” Tilley said.   Participants will be in the phase III study for five to seven years.    PD is a degenerative disorder of the brain in which patients develop symptoms such as progressive tremor, slowness of movements, and stiffness of muscles. It affects at least 1 million people in the United States. Although certain drugs, such as levodopa, can reduce the symptoms of PD, no proven treatments can slow the progressive deterioration in function.   Creatine is marketed as a nutritional supplement. Studies have suggested that it can improve the function of mitochondria, which produce energy inside cells. It also may act as an antioxidant that prevents damage from compounds that are harmful to cells in the brain. In a mouse model of PD, creatine is able to prevent loss of the cells that are typically affected.   “Creatine, or any compound that may slow the progression of PD, could have very important long-term benefits for people who are living with this disease,” said John R. Marler, M.D., NINDS associate director for clinical trials.   The study will enroll people who have been diagnosed with PD within the past five years and who have been treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Many of the symptoms of PD result from the loss of dopamine, a neurotransmitter that helps to control movement. Half of the participants will receive creatine and half will receive a placebo. Neither the participants nor their doctors will know which treatment they receive.   The study is designed to include a broad range of people, with special efforts to recruit a diverse population that is similar to the makeup of the population with PD in the United States. The investigators will measure disease progression using standard rating scales that measure quality of life, ability to walk, cognitive function, and the ability to carry out other activities of daily living.   Avicena Group, Inc. will provide the creatine and the placebo for the study.   People interested in participating in this or other medication trials can obtain more information by calling the Movement Disorders Program at MUSC at 792-7262 or visiting http://www.muschealth.com/movementdisorders. Information from the national clinical trial coordinating center may be obtained by e-mailing info@parkinsontrial.org or visit http://www.parkinsontrial.org.     Friday, April 6, 2007 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.