Clinical Center for The Parkinson Disease Neuroprotection Clinical Trial

描述（由申请人提供）：本提案的目标是作为临床研究中心参与早期帕金森病（PD）患者神经保护剂的探索性试验。PD是一种缓慢进展的神经系统疾病，可导致严重残疾。目前的治疗方法不会改变疾病的进程。然而，已经确定了许多新的化合物，它们有可能减缓甚至停止PD的进展。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于退化，它们将延缓甚至预防数百万患有PD的患者的严重残疾。我们这个项目的主要目标是保留目前登记的神经保护研究受试者， 试点研究LS-1，以及继续参与后续的III期试验，解决PD的疾病修饰治疗。佛罗里达大学将作为一个网站与两个分支机构在两个UF附属运动障碍临床试验中心：尚兹在盖恩斯维尔和尚兹在杰克逊维尔。这两个研究中心都将作为佛罗里达大学Tianner下的联盟研究中心，以在之前的NET-PD试验中成功招募的一些当前联盟中心为模型。随着两个高品质的运动障碍中心位于种族多元化的大都市地区服务几乎整个退伍军人和非退伍军人人口的中北部和东北部佛罗里达，我们预计很容易保留目前登记的科目，以及在未来的研究招聘。每个中心及其研究者在PD多中心试验中的成功参与、入组和合作历史令人印象深刻。招募和招生UF中心的调查员是运动障碍的研究员培训。此外，我们致力于保护所有人体试验受试者，并将积极努力留住目前入组的受试者。这些是我们的最高优先事项。在每个机构，将尽一切努力确保保留当前入组的受试者，我们对此非常承诺。

DESCRIPTION (provided by applicant): 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 objectiv with this project will be to retain the currently enrolled research subjects in the neuroprotection pilot study LS-1, as well as continue participation in subsequent phase III trials addressing disease modifying therapy in PD. The University of Florida will act as one site with two branches at two UF-affiliated Movement Disorder Clinical Trial Centers: Shands at Gainesville and Shands at Jacksonville. Both sites will be acting as consortia sites under the tianner of the University of Florida, modeled after some of the current consortia Centers that successfully recruited as a group in the previous NET-PD trials. With two high-quality Movement Disorders Centers located in ethnically-diverse metropolitan areas serving almost the entire veteran and non-veteran population of North-Central and North-Eastern Florida, we anticipate easy retention of the currently enrolled subjects as well as recruitment in future studies. Each Center and its investigators carry an impressive history of successful participation, enrollment and collaboration in PD multi-center trials. The recruiting and enrolling investigators at the UF Centers are fellowship-trained in Movement Disorders. Furthermore, we are committed to the protection of all human trials subjects and will actively work to retain currently enrolled subject. These are our highest priorities. At each institution, every possible effort will be performed to ensure retention of the currently enrolled subjects, which we are extremely commited to.