Clinical Center for the Parkinson Disease Neuroprotection Clinical Trial

该提案的目标是作为临床研究中心参与神经保护剂的探索性试验 早期帕金森病（PD）患者。PD是一种缓慢进展的神经系统疾病， 导致严重残疾。目前的治疗方法不会改变疾病的进程。但若干 新的化合物已被确定，有可能减缓或甚至停止进展， 警局如果这些化合物中的任何一种真的可以保护存活的神经元免于退化，它们将延缓甚至 预防数百万PD患者的严重残疾。我们的首要目标是 该项目将招募和保留神经保护试点研究和后续研究的研究对象 第三阶段试验。佛罗里达大学将作为一个网站与3个平等的分支机构对3个UF附属 运动障碍临床试验中心：Shands @ Gainesville、马尔科姆兰德尔退伍军人医疗中心和 Shands @杰克逊维尔。这三个网站将作为联盟网站的旗帜下的大学 佛罗里达，仿照一些目前的财团中心，成功地招募作为一个集团在 前2个试点NET-PD试验。3个高质量的运动障碍中心位于2个种族多样化的 大都市区几乎为中北部和北部的所有退伍军人和非退伍军人提供服务， 在佛罗里达东部，我们预计每月可轻松招募至少2例PD患者（总计24例/年）， 试点研究和大型简单的III期试验。每个中心及其调查人员都有一个令人印象深刻的 PD多中心试验中成功参与、入组和协作的历史。所有3个招聘和 在3 UF中心招生调查员是运动障碍的研究金培训。而且我们 致力于保护所有人体试验受试者，并将积极尝试招募女性， 种族/少数民族。这些是我们的最高优先事项。在Shands @ Gainesville，我们将促进 在佛罗里达大学少数民族事务办公室的协助下招募少数民族 医学院，在尚兹@杰克逊维尔，少数民族招聘也将是优先考虑的1/3， 杰克逊维尔市的种族歧视被认为是种族歧视。

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.