Parkinson's Disease Neuroprotection Trial

这项提议的目标是作为临床站点参与全国神经保护研究 帕金森病(Net-PD)。已经设计了一些试验性研究来测试这种潜力 神经保护剂以及验证研究设计和方法。试验性研究的结果将 用于选择关键研究的试剂。作为一个临床站点，我们的主要目标将是招募和 保留研究对象参与拟议的临床试验。我们计划每年招募至少2名患者 在30个月的试验招募阶段(60名患者)。我们建议建立以下伙伴关系 西北大学两个帕金森氏症和运动障碍中心；市中心校园 还有埃文斯顿校区。这两个校区都有成熟的患者基础，训练有素的人员，以及 在PD多中心临床试验的设计和实施方面有丰富的经验。两个校区都有跑道 在PD的所有阶段成功招募和保留研究参与者的记录。我们还将有 在杰西·布朗退伍军人管理局中心接触帕金森病患者，以提高注册人数和多样性 研究人群。 我们愿意与其他中心合作进行一项或多项临床试验。我们也 准备承担其他职责，可能包括：与协调中心协作 和生物统计中心，参与研究方案和操作的合作设计 手册，与数据审计和研究监测人员合作，同意发布在我们网站上收集的数据 只有按照研究发表委员会制定的指导方针，才能采取所有 采取适当措施保护人类受试者，并确保两性和 研究中的种族和少数民族。

The goal of this proposal is to participate as a clinical site in the nation-wide study of neuroprotection in Parkinson's disease (NET-PD). A number of pilot studies have been designed to test the potential neuroprotective agents as well as to verify study design and methodology. The results of the pilot studies will be used to select the agent for the pivotal study. As a clinical site, our primary objective will be to recruit and retain research subjects to participate in the proposed clinical trial. We plan to recruit at least 2 patients per month during the 30 months recruitment phase of the trial (60 patients). We propose partnership between two Parkinson's disease and Movement Disorders Center at Northwestern University; downtown campus and Evanston campus. Both campuses have an established patient base, highly trained personnel, and extensive experience in design and conduct of multicenter clinical trials in PD. Both campuses have atrack record of successful recruitment and retention of research participants at all stages of PD. We also will have access to PD patient population at the Jesse Brown VA Center to enhance the enrollment and diversityof the study population. We are willing to cooperate with the other centers in conduct of one or more clinical trials. We also are prepared to have additional responsibilities that might include: collaboration with the coordinating center and biostatistical center, participation in the cooperative design of the study protocols and operations manuals, cooperation with data audits and study monitors, agreement to publish data collected at our site only in accordance with the guidelines established by the study publications committee, to take all appropriate measures to protect human subjects and to ensure adequate representation of genders and racial and ethnic minorities in the study.