Parkinson Disease Neuroprotection Clinical Trial

描述(由申请人提供)：此申请是为了继续NIH帕金森氏病探索性试验(Net-PD)。NETPD旨在招募患者参加治疗帕金森氏病(PD)的新药物的一系列先导性研究和临床试验。临床站点的作用是识别、筛选、登记、治疗和跟踪HES试验中的患者，并将数据及时报告给数据协调中心，并报告纳入患者的不良反应。招募网站将提供高质量的临床评估、数据输入和管理，并符合为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、第三阶段的临床试验，旨在确定肌酸是否比安慰剂更有效地减缓了患有早期帕金森病的帕金森病患者的下降。2007年开始招生，2010年5月截止招生。重点是继续对受试者进行纵向评估，确保最大限度地保留。 另一项探索性的Net-PD试验最近已经开始招募患者。一项关于吡格列酮治疗早期帕金森病的多中心、双盲、安慰剂对照的II期研究评估了吡格列酮对帕金森病进展的影响以及其有效性、安全性和耐受性。招生从2012年开始，预计将持续到2015年。 佛蒙特州大学医学院(UVM/COM-SITE 137)和达特茅斯-希区柯克医学中心(DHMC-SITE 155)的神经学项目已经证明，他们有能力整合他们的努力，并在该地区合作，提供出色的临床护理，并无缝整合Net-PD的研究目标。总体而言，我们的联盟已经在LS1招募了58名患者，并预计在2012年8月达到我们的FS-ZONE目标。此外，我们在治疗中对受试者的留存率很高(前10%)。我们的计划正在努力提高和维持疗效，以便我们仍将是Net-PD的主要贡献者。

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.