Parkinson's Disease Neuroprotection Trial

描述(由申请人提供)：本提案的目标是作为临床站点参与全国帕金森氏病神经保护研究(NET-PD)。已经设计了一些试验性研究来测试潜在的神经保护剂，并验证研究设计和方法。初步研究的结果将被用来选择关键研究的试剂。作为一个临床网站，我们的主要目标将是招募和保留研究对象，以参与拟议的临床试验。我们计划在30个月的试验招募阶段每月至少招募2名患者(60名患者)。我们建议西北大学的两个帕金森氏病和运动障碍中心建立合作伙伴关系；市中心校园和埃文斯顿校园。这两个校区都有成熟的患者基础，训练有素的人员，以及在设计和实施PD多中心临床试验方面的丰富经验。这两个校区都有成功招募和留住PD各个阶段的研究参与者的记录。我们还将访问杰西·布朗退伍军人管理局中心的帕金森病患者群体，以提高研究人群的登记人数和多样性。我们愿意与其他中心合作进行一项或多项临床试验。我们还准备承担其他责任，包括：与协调中心和生物统计中心合作，参与研究方案和操作手册的合作设计，与数据审计和研究监督员合作，同意仅根据研究发表委员会制定的指导方针公布在我们网站收集的数据，采取一切适当措施保护人类受试者，并确保研究中性别、种族和少数民族的充分代表性。

DESCRIPTION (provided by applicant): 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 a track 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 diversity of 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.