Researchers at the University of Rochester Medical Center are leading one of the largest clinical trials ever for Parkinson's disease.
The study, which will examine whether or not creatine can slow the progression of the disease, is sponsored by the National Institutes of Health (NIH). While creatine is not an approved therapy for Parkinson's or any other condition, it is widely thought to improve exercise performance and is marketed as a nutritional supplement.
URMC neurologist Karl Kieburtz, M.D. will serve as principal investigator of the study which will involve 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 Parkinson's.
Kieburtz is the director of the University of Rochester's Clinical Trials Coordination Center (CTCC), which serves as the hub for some of the world's largest networks for clinical trials of new treatments for neurological conditions. URMC physicians have designed and headed some of the largest clinical trials ever in the treatment of several neurological diseases, including Parkinson's and Huntington's diseases, and they participate in nearly every large nationwide clinical trial of new drugs to treat those diseases as well as Alzheimer's disease.
The CTCC is home to the Parkinson Study Group which consists of more than 350 active investigators, coordinators and scientists from approximately 85 sites located throughout the United States and Canada. The Group has carried out more than 35 multi-center trials examining the symptomatic and neuroprotective effects of experimental interventions in Parkinson's disease and has partnered with numerous pharmaceutical companies and NIH in bringing five new drugs for Parkinson's disease to the market: deprenyl, lazabemide, pramipexole, clozapine, and entacapone.
The new trial is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). 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 Parkinson's.
Parkinson's disease 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 one million people in the United States. Although certain drugs, such as levodopa, can reduce the symptoms of the disease, there are no proven treatments that can slow the progressive deterioration in function.
Creatine is an organic acid that 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 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.
Individuals interested in participating in this study can obtain more information by calling 1-800-352-9424, emailing [email protected], or visiting http://www.parkinsontrial.org/ to see a list of study sites.