MSU Parkinson Disease Clincal Center

描述(由申请人提供)：这是密歇根州立大学(MSU)神经病学系作为参与NINDS帕金森病探索性试验(NET-PD)财团的临床站点的续签申请。Net-PD的目标是证明神经保护剂在减缓帕金森病(PD)进展方面的有效性。这项应用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-简单研究设计比较安慰剂和肌酸(LS-1研究)。密歇根州立大学的Net-PD网站在最初的资助期间招募了45名受试者参加这项研究，并将继续跟踪这些受试者，直到2015年5月。密歇根州立大学Net-PD网站还将继续参与关于吡格列酮(FS-ZONE)和一种可能的PD疾病修饰药物的第二阶段研究，此外，还将参加和领导几个写作重点小组就迄今收集的数据(FSI和FS2数据集以及LS-1的基线数据集)生成手稿。 该提案记录了密歇根州立大学经验丰富的临床研究人员在正在进行的Net-PD LS-1研究中的表现，该研究正在积极跟踪43名受试者。密歇根州密歇根州密歇根州立大学的中心位置，加上分散的全州医学院校园系统，一直是LS-1研究招募早期/轻度PD患者的理想选择。与地区神经学家、当地支持团体和密歇根帕金森基金会建立了关系，密歇根帕金森基金会是全州范围内最重要的PD支持组织，增强了密歇根州立大学独特的招聘基础。与区域神经学家和运动障碍专科提供者的合作促进了有效和全面的患者查明，并将有助于保留。密歇根州立大学的神经学家和一名在运动障碍、患者护理和临床试验方面具有专业知识的研究协调员将继续跟踪患者。密歇根州立大学的网站将继续借鉴在类似的神经疾病多中心研究中进行的大型纵向临床试验的先前经验，以促进对研究方案和监管问题的遵守，同时努力在Net-PD LS-1研究的关键后续年份最大限度地保留患者。

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.