Michigan State University Parkinson Disease Clinical Center

密歇根州立大学帕金森病临床中心

• 批准号: 7558930
• 负责人: JOHN L GOUDREAU
• 金额: $ 13.14万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-17 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7558930
• 关键词: Accounting; Affect; Americas; Area; Bradykinesia; Brain Stem; Cessation of life; Clinical; Clinical Research; Clinical Trials; Collaborations; Conduct Clinical Trials; Controlled Clinical Trials; Cytoplasmic Inclusion; Data; Deterioration; Disease; Disease Progression; Double-Blind Method; Dyskinetic syndrome; Economic Burden; Elderly; Enrollment; Environment; Etiology; Excess Mortality; Exclusion Criteria; Facilities and Administrative Costs; Fostering; Foundations; Gait; Impairment; Incidence; Inclusion Bodies; Levodopa; Lewy Bodies; Life Expectancy; Location; Medical; Michigan; Morbidity - disease rate; Motor; Movement Disorders; Muscle Rigidity; Neurodegenerative Disorders; Neurologist; Neurology; Neurons; Neuroprotective Agents; Nursing Homes; Parkinson Disease; Pathogenesis; Patient Recruitments; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Pigments; Placebo Control; Prevalence; Provider; Public Health; Recruitment Activity; Reflex action; Research Personnel; Rest Tremor; Risk Factors; Staging; Study Subject; Substantia nigra structure; Support Groups; Symptoms; System; Testing; Translating; Tremor; United States; Universities; Visit; base; cost; data acquisition; disability; dopaminergic neuron; effective therapy; experience; medical schools; meetings; nervous system disorder; neuroprotection; novel; pars compacta; pre-clinical; premature; statistical center; symptom management

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 & 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.

这是密歇根州立大学（MSU）神经病学系的申请 帕金森氏病神经保护临床试验联盟的临床中心。这个目的 临床试验证明了一种或几种神经保护剂在减慢进展方面的功效 帕金森氏病（PD）的大型双盲，安慰剂对照临床试验。 MSU帕金森 疾病临床中心将识别，招募和维持轻度，早期PD患者（Hoehn＆Yahr <2， 在该多中心临床试验的试点和III期试验组件中，在症状发作的5年内）。 该提案记录了经验丰富的患者招募和保留潜力 MSU的临床人员。总的来说，MSU的主要研究人员和神经病学部 平均有近700例PD患者就诊，每年约有125名新的PD患者。基于 直接图表审查的数据，如果新患者中有55％将符合纳入和排除标准 包括服用有症状药物的患者；如果有症状的人，20％将符合标准 药物被排除在外。大量的潜在合格案件反映了转介模式 MSU神经病学系，这是大部分地区的主要和次要转诊的重点 其他神经科医生相对乏味的国家。 密歇根州立大学在密歇根州的中心位置，再加上分散的全州医疗 学校校园系统是最大程度的患者招募的理想选择。与地区建立的关系 神经科医生，当地支持小组以及密歇根州帕金森基金会，全州PD 支持组织将增强MSU的独特招聘基础。与大学合作 密歇根州以及区域神经科医生和运动障碍子专业提供者将培养 有效而全面的患者确定。 MSU神经病学家具有运动障碍专业知识 将注册并关注患者。 MSU以前在大型纵向临床试验中的经验提供了 在类似的多中心研究中，在招募，保留和数据获取方面的验证记录 疾病。 MSU是一个最佳环境，非常成功地参与了帕金森氏病 神经保护临床试验。