Clinical Center for the Parkinson Disease Neuroprotection Clinical Trial

该提案的目标是作为临床现场参与神经保护剂的探索性试验。 适用于早期帕金森氏病(PD)患者。帕金森病是一种进展缓慢的神经疾病，它 会导致严重的残疾。目前的治疗方法并不能改变疾病的进程。然而，一些人 新的化合物已经被发现，有可能减缓甚至阻止癌症的进展。 警察。如果这些化合物中的任何一种能够真正保护存活的神经元免受退化，它们将延迟甚至 预防数百万帕金森病患者的严重残疾。我们的主要目标是 该项目将在神经保护先导研究和后续研究中招募和保留研究对象 第三阶段试验。佛罗里达大学将作为一个网站，在3个UF附属大学上有3个相等的分支机构 运动障碍临床试验中心：斯汉兹@盖恩斯维尔，马尔科姆·兰德尔退伍军人医学中心，以及 斯汉兹@杰克逊维尔。所有这三个地点都将作为财团地点，打着加州大学的旗号 佛罗里达州，仿照目前在美国成功招募的一些财团中心 前2个试点NET-PD试验。拥有3个高质量的运动障碍中心，位于2个不同种族的人 大都市区为中北部和北部的几乎所有退伍军人和非退伍军人提供服务- 在佛罗里达州东部，我们预计每月至少招募2名PD患者(总计24名/年) 先导性研究和大型简单第三阶段试验。每个中心及其调查人员都携带着令人印象深刻的 帕金森病多中心试验的成功参与、登记和协作的历史。所有3个招聘和 在3个UF中心招募的调查人员接受了运动障碍方面的团契培训。此外，我们 致力于保护所有人体试验对象，并将积极尝试招募女性和 少数族裔。这些都是我们的首要任务。在Sands@Gainesville，我们将为 在佛罗里达大学少数群体事务办公室的协助下招募少数群体 斯汉兹@杰克逊维尔医学院，少数族裔的招聘也将是优先事项，因为三分之一的 杰克逊维尔CITV的土尔化被认为是种族问题。

The goal of this proposal is to participate as a clinical site in exploratory trials of neuroprotective agents for patients with early Parkinson's disease (PD). PD is a slowly progressive neurological disorder, which results in severe disability. Current therapies do not alter the course of the disease. However, a number of new compounds have been identified that have the potential to slow down or even halt the progression of PD. If any of these compounds can truly protect viable neurons from degenerating, they would delay or even prevent significant disability in the millions of patients who suffer from PD. Our primary objective with this project will be to recruit and retain research subjects in the neuroprotection pilot studies and subsequent phase III trials. The University of Florida will act as one site with 3 equal branches on 3 UF-affiliated Movement Disorder Clinical Trial Centers: Shands @ Gainesville, Malcom Randall VA Medical Center, and Shands @ Jacksonville. All three sites will be acting as consortia sites under the banner of the University of Florida, modelled after some of the current consortia Centers that successfully recruited as a group in the first 2 pilot NET-PD trials. With 3 high-quality Movement Disorders Centers located in 2 ethnically-diverse metropolitan areas serving almost the entire veteran and non-veteran population of North-Central and North- Eastern Florida, we anticipate easy recruitment of at least 2 PD patients per month (24 total/year) for both the pilot studies and the large simple phase III trial. Each Center and its investigators carry an impressive history of successful participation, enrollment and collaboration in PD multi-center trials. All 3 recruiting and enrolling investigators at the 3 UF Centers are fellowship-trained in Movement Disorders. Furthermore, we are committed to the protection of all human trials subjects and will actively try to recruit women and racial/ethnic minorities. These are our highest priorities. At Shands @ Gainesville, we will facilitate recruitment of minorities with the assistance of the Office of Minority Affairs at the University of Florida College of Medicine, At Shands @ Jacksonville, minority recruitment will also be the priority as 1/3 of the Dooulation of the citv of Jacksonville is considered ethnic.