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.