Parkinson Disease Neuroprotection Clinical Trial

描述（由申请人提供）：本申请用于继续NIH帕金森病探索性试验（NET-PD）。NETPD旨在招募患者参加一系列用于治疗帕金森病（PD）的新药的试点研究和临床试验。临床研究中心的作用是识别、筛查、招募、治疗和随访这些试验中的患者，并及时向数据协调中心报告数据，并报告招募患者的不良反应。招募中心将提供高质量的临床评估、数据录入和管理，并符合试验概述的所有监管法规。目前，NET-PD正在进行LS-1研究，这是一项多中心，双盲，III期临床试验，旨在确定肌酸是否比安慰剂更有效地减缓早期治疗PD患者的PD下降。招生于2007年开始，2010年5月结束。重点是继续对受试者进行纵向评估，确保最大限度地保留受试者。 另一项探索性NET-PD试验最近开始招募患者。一项在早期PD中评价吡格列酮的多中心、双盲、安慰剂对照II期研究，评估吡格列酮对PD进展的影响以及疗效、安全性和耐受性。招生于2012年开始，预计将持续到2015年。 佛蒙特大学医学院（UVM/COM-Site 137）和达特茅斯-希区柯克医学中心（DHMC-Site 155）的神经病学项目已经证明了他们整合努力并在该地区合作的能力，以提供出色的临床病例和NET-PD研究目标的无缝集成。总体而言，我们的联盟已在LS 1中招募了58名患者，并预计在2012年8月之前达到FS-ZONE的目标。此外，我们的治疗受试者保留率非常高（前10%）。我们的计划正在努力提高，以及维持，有效性，使我们将仍然是一个主要贡献者净PD。

DESCRIPTION (provided by applicant): This application is for the continuation of the NIH Exploratory Trials in Parkinson's Disease (NET-PD). NETPD was designed to enroll patients in a series of pilot studies and clinical trials of new agents for the treatment of Parkinson's Diseas (PD). The role of the clinical sites is to identify, screen, enroll, treat, and follow patients in hese trials as well as report data in a timely manner to the data coordinating center and to report adverse efects among enrolled patients. The recruiting sites will provide high quality clinical assessments, data entry and management and meet all regulatory statutes outlined for the trials. 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 decline in PD patients with early, treated PD. Enrollment began in 2007 and closed in May of 2010. The key focus is to continue longitudinal assessment of subjects, ensuring maximum retention. Another exploratory NET-PD trial has recently begun enrolling patients. A multi-center, double-blind, placebo-controlled phase II study of pioglitazone in early PD assesses the impact of pioglitazone on the progression of PD as well as the efficacy, safety and tolerability. Enrollment began in 2012 and is expected to continue through 2015. The Neurology programs at the University of Vermont College of Medicine (UVM/COM-Site 137) and Dartmouth-Hitchcock Medical Center (DHMC-Site 155) have demonstrated the ability to integrate their efforts and to work collaboratively in this region to provide excellent clinical cae and seamless integration of the research goals of NET-PD. Collectively, our consortium have enrolled 58 patients in LS1 and expect to reach our target for FS-ZONE by August of 2012. In addition, we have excellent retention of subjects on therapy (top 10%). Our programs are working to enhance, as well as sustain, efficacy so that we will remain a major contributors to NET-PD.