USF site for national study testing creatine for Parkinson's disease
Tampa, FL (March 22, 2007) – The University of South Florida Parkinson’s and Movement Disorders Center will participate in a large-scale national clinical trial to determine if the nutritional supplement creatine can slow the progression of Parkinson’s disease (PD). 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 trial, which begins today, is sponsored by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NIH-NINDS).
The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. The USF Parkinson’s Disease and Movement Disorders Center is one of 51 medical centers in the United States and Canada that will be recruiting patients as part of an effort to enroll 1720 people with early-stage PD. USF is the only site on the West Coast of Florida.
“This is a landmark trial that will explore whether we can improve long-term outcomes for patients with Parkinson’s disease,” said local principal investigator Robert A. Hauser, MD, professor of neurology and director of the USF Parkinson’s Disease and Movement Disorders Center. “We want to identify therapies that will slow, and perhaps one day stop, the progression of the underlying disease process.”
“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 possible with existing therapies.” Currently no treatment has been shown to slow the progression of PD.
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). USF has been affiliated with the program since 2002, and Dr. Hauser has served on the steering committee that identifies promising therapies and designs trials to test them since 2005. The NIH has organized this large network of sites to allow researchers to work with PD 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 PD.
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, 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 PD, creatine is able to prevent loss of the cells that are typically affected.
The study will enroll people who have been diagnosed with PD within the past five years and treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Many 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 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 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 locally can call (813) 844-4455. For additional information, call NINDS at 1-800-352-9424, email email@example.com, or visit 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.
USF Health is a partnership of the University of South Florida’s colleges of medicine, nursing, and public health; the schools of basic biomedical sciences and physical therapy & rehabilitation sciences; and the USF Physicians Group. It is a partnership dedicated to the promise of creating a new model of health and health care. One of the nation’s top 63 public research universities as designated by the Carnegie Foundation for the Advancement of Teaching, USF received more than $310 million in research contracts and grants last year. For more information visit, www.health.usf.edu.