This is a renewal application for the Michigan State University (MSU) Department of Neurology as a participating clinical site in the NINDS Exploratory Trials in Parkinson Disease (NET-PD) consortium. The goal of the NET-PD is demonstrate efficacy of neuroprotective agents in slowing the progression of Parkinson Disease (PD). This application is focused on the ongoing in a large, double blind, placebo controlled, phase III clinical trial comparing placebo versus creatine using a large-simple study design (the LS-1 study). The MSU NET-PD site enrolled 45 subjects into this study during the initial funding period and will continue to follow these subjects until May, 2015. The MSU NET-PD site will also continue to participate in the phase II study of pioglitazone (FS-ZONE) and a possible disease modifying drug in PD, in addition to participating and leading several writing focus groups to generate manuscripts on the data collected thus far (FSI and FS2 data sets and the baseline data set for LS-1). This proposal documents the performance of the experienced clinical research staff at MSU in the ongoing NET-PD LS-1 study, which is actively following 43 subjects. The central location of MSU within the state of Michigan, combined with the dispersed statewide medical school campus system, has been ideal for early/mild PD patient recruitment for the LS-1 study. Established relationships with area neurologists, local support groups and with the Michigan Parkinson Foundation, the premier statewide PD support organization enhance the unique recruitment base at MSU. Collaboration with regional neurologists and movement disorders subspecialty providers has fostered efficient and comprehensive patient ascertainment and will aid in retention. MSU neurologists and a research coordinator with expertise in movement disorders patient care and clinical trials will continue to follow patients. The MSU site will continue to draw on prior experience with large, longitudinal clinical trials in similar multi-centr studies of neurological disease to promote compliance with study protocols and regulatory issues while striving to maximize patient retention during the critical follow-up years of NET-PD LS-1 study.
Parkinson disease (PD) is a prevalent neurodegenerative disease and there is no current treatment to slow the natural history of increasing disability associated with disease progression. The NINDS Exploratory Trials in PD seeks to identify therapies to slow or halt progression in PD. A phase III, large simple trial of creatine versus placebo holds the promise of identifying an effective disease modifying therapy for PD