Southeastern Michigan Parkinson's Disease Program

描述（由申请人提供）：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氏病项目描述了研究经验、设施和操作能力，这些合作站点将密切合作：威廉博蒙特医院系统、临床神经科学中心（CNC）、南菲尔德的帕金森氏病（PD）研究和治疗项目，以及位于底特律的韦恩州立大学医学院（WSU SOM）校园的PD诊所。我们建议在全国范围内招募并开展PD神经保护的随机双盲临床试验。CNC由国家帕金森基金会指定为密歇根州的卓越中心，开发了该州最大的PD患者基础和转诊网络。近20年来，CNC一直是全国开展PD从1期到4期临床研究的领先机构之一。CNC与该地区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服务提供者的广泛联系应该最大限度地增加招募新发PD患者的机会。这两个地点将增强研究参与者的多样性，特别是华盛顿州立大学SOM为大量内城人口和一个主要的退伍军人管理医疗中心提供服务。CNC在PD药物研究方面的丰富经验涉及由制药行业，美国国立卫生研究院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）。首席研究员热衷于参与多地点合作项目，并能在选择和协调研究方面发挥领导作用。本申请还讨论了三种药理学药物的概念，这些药物可以在初步研究中进行调查，如果有希望，可以在评估神经保护的多中心临床试验中进行调查。

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.