Michigan State University Parkinson Disease Clinical Center

描述（由申请人提供）：这是一份申请密歇根州立大学（MSU）神经内科成为帕金森病神经保护临床试验联盟临床中心的申请。本临床试验的目的是在一项大型、双盲、安慰剂对照的临床试验中证明一种或几种神经保护剂在减缓帕金森病（PD）进展方面的功效。密歇根州立大学帕金森病临床中心将在该多中心临床试验的试点和III期试验组成部分中识别、招募和维持轻度、早期PD患者（Hoehn和Yahr < 2，症状出现5年内）。该提案记录了密歇根州立大学经验丰富的临床工作人员出色的患者招募和保留潜力。总的来说，主要研究人员和密歇根州立大学神经病学部门平均每年有近700名PD患者就诊，并看到大约125名新的PD患者。根据直接图表回顾的数据，如果纳入服用对症药物的患者，55%的新患者符合纳入和排除标准；如果排除那些服用对症药物的人，20%的人符合标准。大量潜在符合条件的病例反映了密歇根州立大学神经内科的转诊模式，这是来自该州大部分地区的初级和二级转诊的焦点，而其他神经科医生的服务相对不足。密歇根州立大学位于密歇根州的中心位置，加上分散的全州医学院校园系统，是最大限度地招募患者的理想选择。与地区神经学家、当地支持团体以及密歇根州帕金森基金会（全州首屈一指的帕金森病支持组织）建立的关系，将增强密歇根州立大学独特的招聘基础。与密歇根大学，以及地区神经科医生和运动障碍专科医生的合作，将促进有效和全面的患者确定。具有运动障碍专业知识的密歇根州立大学神经科医生将登记并跟踪患者。密歇根州立大学之前在大型纵向临床试验方面的经验为类似的神经疾病多中心研究的招募、保留和数据获取提供了可靠的跟踪记录。密歇根州立大学是帕金森病神经保护临床试验的最佳参与环境。

DESCRIPTION (provided by applicant): This is an application for the Michigan State University (MSU) Department of Neurology to become a clinical center in the Parkinson Disease Neuroprotection Clinical Trial consortium. The objective of the this clinical trial is demonstrate the efficacy of one or several neuroprotective agents in slowing the progression of Parkinson Disease (PD) in a large, double blind, placebo-controlled clinical trial. The MSU Parkinson Disease Clinical Center will identify, enroll, and maintain patients with mild, early PD (Hoehn and Yahr < 2, within 5 years of symptom onset) in the pilot and Phase III trial components of this multicenter clinical trial. This proposal documents the outstanding patient recruitment and retention potential of the experienced clinical staff at MSU. Collectively, the primary investigators and the Department of Neurology at MSU have an average of nearly 700 PD patient visits and see approximately 125 new PD patients per year. Based on data from direct chart review, 55% of the new patients would meet the inclusion and exclusion criteria if patients taking symptomatic medications are included; 20% would meet criteria if those taking symptomatic medications were excluded. The large pool of potentially eligible cases reflects the referral pattern for the Department of Neurology at MSU, which is the focus of primary and secondary referrals from a large area of the state that is relatively underserved by other neurologists. The central location of MSU within the state of Michigan, combined with the dispersed statewide medical school campus system, is ideal for maximal patient recruitment. Established relationships with area neurologists, local support groups and with the Michigan Parkinson Foundation, the premier statewide PD support organization, will enhance the unique recruitment base at MSU. Collaboration with the University of Michigan, as well as regional neurologists and movement disorders subspecialty providers, will foster efficient and comprehensive patient ascertainment. MSU neurologists with expertise in movement disorders will enroll and follow patients. MSU's previous experience with large, longitudinal clinical trials provide a proven track record in recruiting, retention and data acquisition in similar multi-center studies of neurological disease. MSU is an optimum environment highly successful participation in the Parkinson Disease Neuroprotection Clinical Trial.