Southeastern Michigan Parkinson's Disease Program

描述(申请人提供)：本申请响应RFA-NS-02-010(“帕金森病神经保护试验：临床中心”)。密歇根东南部帕金森病项目描述了将密切合作的合作网站的研究经验、设施和运营能力，这些网站包括：William Beaumont医院系统、临床神经科学中心(CNC)、南菲尔德的帕金森病(PD)研究和治疗项目，以及底特律韦恩州立大学医学院(WSU SOM)的PD诊所。我们建议参与一项全国性的努力，招募和进行帕金森病神经保护的随机双盲临床试验。该中心被国家帕金森基金会指定为密歇根州卓越中心，发展了该州最大的帕金森病患者基础和转诊网络。近20年来，该中心一直是美国进行帕金森病1-IV期临床研究的领先场所之一。该中心与该地区的PD患者社区以及密歇根州、俄亥俄州和安大略省西南部的医疗机构建立了广泛的联系，应该会最大限度地增加招募新PD患者的机会。这两个地点将增强研究参与者的多样性，特别是通过WSU SOM为市中心的大量人口和一个主要的退伍军人管理医疗中心提供的服务。CNC在PD药物研究方面的丰富经验涉及由制药业、NIH和帕金森研究小组赞助的临床试验(包括几项神经保护研究)。首席研究人员热衷于参与多地点协作计划，并在选择和协调研究方面发挥领导作用。该申请还讨论了三种药理制剂的概念，可以在先导研究中进行研究，如果前景光明，还可以在多中心临床试验中进行神经保护评估。

DESCRIPTION (provided by applicant): This application responds to RFA-NS-02-010 ("Parkinson Disease Neuroprotection Trial: Clinical Centers"). The Southeastern Michigan Parkinson's Disease Program describes the research experience, facilities, and operational capabilities for collaborative sites that will work together closely: the William Beaumont Hospital System, the Clinical Neuroscience Center (CNC), a Parkinson's disease (PD) research and treatment program in Southfield, and the PD clinics at the Wayne State University School of Medicine (WSU SOM) campus in Detroit. We propose to participate in a nationwide effort for recruiting and conducting randomized, double blind clinical trials of neuroprotection for PD. The CNC, designated by the National Parkinson Foundation as Michigan's Center of Excellence, has developed the State's largest PD patient base and referral network. For almost 20 years, the CNC has been one of the nation's leading sites for conducting Phase 1 through IV clinical research in PD. The CNC's extensive affiliations with the region's PD patient community as well as with health providers in Michigan, Ohio, and southwestern Ontario should maximize opportunities for recruiting de novo PD patients. The two sites will enhance the diversity of study participants, especially with the WSU SOM services to a large inner city population and a major Veterans Administration Medical Center.The CNC's extensive experience in PD drug research has involved clinical trials (including several neuroprotection studies) sponsored by the pharmaceutical industry, the NIH, and the Parkinson Study Group. The Principal Investigator is enthusiastic to participate in the multi-site collaborative program and can offer a leadership role in the choice and coordination of studies.This application also discusses concepts for three pharmacological agents that could be investigated in pilot studies and, if promising, in multicenter clinical trials for assessing neuroprotection.