The goal of this application is to collaborate with a coordination center, a biostatistics center, the NINDS program oversite group and 41 study sites throughout the United States for the implementation of a large, multi-center controlled clinical trial. In this trial we propose to recruit, enroll, and evaluate 84 subjects during the conduct of a neuroprotective trial in Parkinson's disease. The Movement Disorders Center (MDC) at Washington University School of Medicine has participated in over 20 clinical trials in Parkinson's disease; nine of these trials were with untreated subjects. As the only academic movement disorder program within a 200 mile radius, the MDC has an extensive primary care referral base necessary to recruit a large number of de novo patients. Initial study recruitment will occur from within the MDC clinical practice. In addition, we will utilize the Greater St. Louis Chapter of the American Parkinson Disease Association (APDA) and the APDA information and referral service to identify newly diagnosed subjects. Other recruitment strategies will include local TV, radio, and print media, web-based advertisements, and free Parkinson's Disease screenings. We propose that the study pilot phase include investigation of the validity and accuracy of electronic data entry using either a web-based or local system. The MDC has pioneered the development of an electronic medical record directly applicable to clinical practice and research studies in movement disorders. In addition, we propose that during the pilot phase of the study, a biomarker such as [18F]FDOPA PET undergo necessary validation to determine if the study medication interferes with uptake of the biomarker. If a biomarker proves to be unaffected by the study medication and meets other criteria proposed in this application, the biomarker could be used to assess disease progression in a sub-set of study subjects. The MDC at Washington University School of Medicine provides the breadth of clinical and basic research experience required to be a productive site in this large, multi-center neuroprotective trial in PD.
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