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Vanderbilt University Medical Center to Conduct Phase III Clinical Trial of Creatine for Parkinson’s Disease

Mar. 22, 2007, 8:25 AM

Vanderbilt University Medical Center (VUMC) will participate in a large-scale national clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson’s disease. While creatine is not an approved therapy for Parkinson’s or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for Parkinson’s was identified by researchers through a new rapid method for screening potential compounds. The trial, which begins today, is sponsored by the National Institutes of Health (NIH). The double-blind, placebo-controlled, Phase III study is one of the largest Parkinson’s clinical trials to date. VUMC is one of 51 medical centers in the United States and Canada that will be recruiting patients as part of an effort to enroll 1,720 people with early-stage Parkinson’s. The primary investigator at VUMC is John Fang, M.D., of the Neurology department. “This study represents the next major step in the quest for a medicine that can slow down the progression of Parkinson’s disease,” Fang said. “Earlier studies have shown promising results, but without a long-term study, we cannot know for sure.” “This study is an important step. We are pleased to have so many sites participating in this study, which may help us move more quickly toward developing a therapy that could change the course of this devastating disease,” says Elias A. Zerhouni, M.D., director of the NIH. “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.” Currently there is no treatment that has been shown to slow the progression of Parkinson’s. The trial is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson’s Disease). VUMC has been affiliated with the program since 2002. The NIH has organized this large network of sites to allow researchers to work with Parkinson’s patients over 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. “This study is an example of our commitment to Parkinson’s research,” said Story C. Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), the NIH institute leading the study. “We are trying to explore every possible option for reducing the burden of this disease.”

Parkinson’s 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, there are no proven treatments that 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 Parkinson’s, creatine is able to prevent loss of the cells that are typically affected. The study will enroll people who have been diagnosed with Parkinson’s 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 Parkinson’s 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 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 study can obtain more information by calling (800) 352-9424, e-mailing info@parkinsontrial.org, or visiting http://www.parkinsontrial.org/ to see a list of study sites. The NINDS is a component of the NIH within the Department of Health and Human Services and is the nation’s primary supporter of biomedical research on the brain and nervous system. The National Institutes of Health — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
### VIA SATELLITE, C-BAND FEED: WEDNESDAY, MARCH 21 3:00 – 3:15 PM ET GA 26, Tr. 11, DL 3920V THURSDAY, MARCH 22 04:30 – 04:45 AM ET GA 25, Tr. 13, DL 3960V THURSDAY, MARCH 22 2:00 – 2:15 PM ET GA 26, Tr. 11, DL 3920V Technical Info DURING FEED ONLY, Quicklink TOC, 212-947-4475 VIA PATHFIRE: STORY #NBN 24744 On the left panel of Pathfire, double click on News Broadcast Network, Story # NBN 24744. This story will be available after 5 PM ET, Wednesday, March 21, 2007. Hard Copy or Feed Information: Dan Schwarzberg, News Broadcast Network, 212-684-8910, ext. 320 Editorial Contact: Margo Warren, 301-496-5924

For More Information: Craig Boerner, Vanderbilt University Medical Center 615-322-4747 craig.boerner@vanderbilt.edu OR Marian Emr or Margo Warren, National Institute of Neurological Disorders and Stroke301-496-5924

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