This application is for the renewal of a NIH Exploratory Trials in Parkinson's Disease (NET-PD) clinical site at Struthers Parkinson's Center, Park Nicollet Health Services. NET-PD was designed to enroll patients in a series of pilot studies and clinical trials of new agents for the neuroprotective treatment of Parkinson's Disease. The role of the clinical sites is to identify, screen, enroll, treat, and follow patients n these trials;to report data in a timely manner to the data coordinating center;and to report adverse effects among enrolled patients. Our site enrolled 10 subjects in the two futility trials o NET-PD (FS1 and FS-TOO) which have been completed. Currently, NET-PD is conducting the LS-1 study, a multi-center, double-blind, phase III clinical trial designed to determine whether or not creatine is more effective than placebo in slowing the clinical decline in PD patients with early, treated PD. Enrollment began in 2007 and was completed in 2010 - all patients will be on treatment and followed for a minimum of 5 years or until the end of the study. Our site enrolled 42 subjects with 29 subjects still actively participating in the study. An additional exploratory tial in Parkinson's disease has been developed utilizing pioglitazone (FS Zone) - enrollment for this study has recently begun at our site. Our site was part of a diversity sub-study initiative aimed at enrolling minority subjects. Although the intervention in this sub-study failed to increase recruitment of diverse populations, the process will inform future clinical trials in Parkinson's disease. Data from the NET-PD studies will also provide a wealth of well-characterized clinical data in a group of patients with early Parkinson's'disease. Research team members from our site have been active participants in NET-PD writing groups and manuscript writing committees using data from FS1 and FSTOO. Members of our research team are named authors on three NET-PD publications, with several other manuscripts in preparation.
Despite advances in the treatment and understanding of the pathophysiology of Parkinson's disease, there are no current therapies that slow or halt the progression of the disease. LSI will help to determine if creatine can slow clinical decline in Parkinson's disease. Further, LSI will provide better information on the course of early PD than is currently available.