Continuation of NET-PD Trials at the University of Michigan

描述（由申请人提供）：目前帕金森病（PD）的药物治疗是姑息性的。目前还没有明确的治疗方法可以阻止或减缓PD的进展。NINDS探索性试验在帕金森病（NET-PD）联盟启动进行临床研究试验，有前景的药物，可以减缓帕金森病的临床进展。密歇根大学卫生系统的临床研究人员和工作人员自NET-PD成立以来一直作为NET-PD站点参与，并积极参与NET-PD组进行的所有临床试验。我们的网站有一个优秀的主题招募和保留记录。我们的网站致力于临床试验的安全进行，并采取了一些措施来确保参与者的安全。我们积极参与了最初的FS-1和FS-TOO无效研究。然后，我们招募了37名受试者参加LS-1肌酸研究，目前正在对33名受试者进行随访（保留率89%）。我们承诺保留和跟踪这33名受试者直至完成LS-1试验。FS-ZONE研究正在研究吡格列酮是否可以减缓PD的临床进展，目前我们已经招募了2名受试者。此外，我们与密歇根州帕金森基金会（MPF）有着密切的联系，MPF是密歇根州帕金森病的主要外行组织，并计划实施一项新举措，以增加和保留少数族裔的入学人数。基于我们之前在NET-PD方面的经验，我们的临床研究基础设施，以及与当地PD社区的联系，我们密歇根大学相信我们已经做好了充分的准备，可以继续作为NET-PD试验的临床中心。我们计划继续与其他NET-PD中心合作，包括协调和统计中心，以完成当前的试验（LS-1和FS-ZONE）。

DESCRIPTION (provided by applicant): Current pharmacotherapy for Parkinson's disease (PD) is palliative. There is no treatment proven unequivocally to arrest or slow progression of PD. The NINDS Exploratory Trials in Parkinson's Disease (NET-PD) consortium was initiated to conduct clinical research trials of promising agents that could slow the clinical progression of PD. The clinical investigators and staff at the University of Michigan Health System have been involved as a NET-PD site since the inception of NET-PD and have been active participants in all clinical trials conducted by the NET-PD group. Our site has an excellent subject recruitment and retention record. Our site is committed to the safe conduct of clinical trials and has several measures in place to ensure participant safety. We actively participated in the original FS-1 and FS-TOO futility studies. We then enrolled 37 subjects in the LS-1 creatine study and are currently conducting follow-up visits on 33 subjects (retention rate 89%). We are committed to retaining and following these 33 subjects through completion of the LS-1 trial. We are also in the process of enrolling subjects for the FS-ZONE study, which is investigating whether pioglitazone can slow down the clinical progression of PD and have enrolled 2 subjects to date. Additionally, we have strong ties with the Michigan Parkinson Foundation (MPF), the major lay organization for PD in Michigan and plan on implementing a new initiative to increase and retain minority enrollment. Based on our previous experience in NET-PD, our clinical research infrastructure, and connection with the local PD community, we at the University of Michigan believe that we are well-equipped to continue serving as a clinical center for the remaining NET-PD trials. We plan on continuing to cooperate with other NET-PD centers, including the Coordination and Statistical Centers towards the goal of completing the current trials (LS-1 and FS-ZONE).