MSU Parkinson Disease Clincal Center

描述（由申请人提供）：这是密歇根州立大学（MSU）神经内科作为NINDS帕金森病探索性试验（NET-PD）联盟参与临床站点的续期申请。NET-PD的目标是证明神经保护剂在减缓帕金森病（PD）进展方面的功效。该申请的重点是正在进行的一项大型、双盲、安慰剂对照的III期临床试验，使用大型简单研究设计（LS-1研究）比较安慰剂和肌酸。MSU NET-PD网站在初始资助期内招募了45名受试者，并将继续跟踪这些受试者至2015年5月。MSU NET-PD站点还将继续参与吡格列酮（FS-ZONE）和一种可能的PD疾病改善药物的II期研究，除了参与并领导几个写作焦点小组，根据迄今收集的数据（FSI和FS2数据集以及LS-1的基线数据集）生成文稿。

DESCRIPTION (provided by applicant): 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.