Parkinson's Disease Neuroprotection Clinical Trial

描述(申请人提供)：帕金森病(PD)是第二种最常见的神经退行性疾病。虽然已经开发了一些对症治疗方法，但还没有确定可以阻止或减缓这种进行性疾病的治疗方法。由于许多原因，我们认为对一种或多种前景更好的药物进行前瞻性临床试验是合适的，以确定它们是否提供益处。这项申请的目的是让加州大学旧金山分校继续作为临床中心参与神经保护剂的合作研究。Net-PD旨在招募患者参加一系列治疗帕金森病的新药物的先导性研究和临床试验。临床SIES的作用是识别、筛选、登记、治疗和跟踪这些试验中的患者；及时向数据协调中心报告数据；以及报告入选患者的不良反应。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临床下降。登记从2007年开始，到2010年5月结束，所有患者都在接受治疗，并进行了至少5年或最多8年的随访，直到2015年5月。2011年5月启动了一项补充试验，并继续进行登记。FS区试验是一项随机、双盲、安慰剂对照的无效性研究，评估吡格列酮预防帕金森病进展的作用。受试者将被跟踪观察44周。

DESCRIPTION (provided by applicant): Parkinson's disease (PD) is the second most common neurodegenerative disorder. While a number of symptomatic therapies have been developed, no treatment has been identified that halts or slows this progressive disorder. For a number of reasons, we believe that it is appropriate to conduct prospective clinical trials of one or more of the more promising agents to determine whether they offer benefit. The aim of this application is for UCSF to continue participation as a clinical center in a collaborative study of neuroprotective agents. NET-PD was designed to enroll patients in a series of pilot studies and clinical trials of new agents for the treatment of Parkinson's disease. The role of the clinical sies is to identify, screen, enroll, treat, and follow patients in these trials; to report data in a timly manner to the data coordinating center; and to report adverse effects among enrolled patients. 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 clinical decline in PD patients with early, treated PD. Enrollment began in 2007 and ended in May of 2010, with all patients on treatment and followed for a minimum of 5 years or up to 8 years, through May 2015. A supplemental futility trial was initiated in May 2011 and continues enrollment. The FS-ZONE trial is a randomized, double-blind placebo-controlled futility study evaluating pioglitazone for the prevention of Parkinson's disease progression. The subjects will be followed for 44 weeks.