Parkinson Disease Neuroprotective Trial: Clinical Center

帕金森病神经保护试验：临床中心

• 批准号: 7568752
• 负责人: Brad A Racette
• 金额: $ 10.56万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7568752
• 关键词: Advertisements; American; Basic Science; Biological Markers; Biometry; Clinical; Clinical Trials; Computerized Medical Record; Controlled Clinical Trials; Development; Disease Association; Disease Progression; Enrollment; Goals; Individual; Investigation; Movement Disorders; National Institute of Neurological Disorders and Stroke; Nerve Degeneration; Neuroprotective Agents; Newly Diagnosed; North America; Online Systems; Parkinson Disease; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Positron-Emission Tomography; Primary Health Care; Printed Media; Radial; Radio; Recruitment Activity; Screening procedure; Services; Site; Study Subject; System; United States; Universities; Validation; Washington; base; clinical practice; control trial; disability; electronic data; experience; medical schools; meetings; programs; research study; uptake

DESCRIPTION (provided by applicant): The goal of this application is to collaborate with a coordination center, a biostatistics center, the NINDS program oversite group and 41 study sites throughout the United States for the implementation of a large, multi-center controlled clinical trial. In this trial we propose to recruit, enroll, and evaluate 84 subjects during the conduct of a neuroprotective trial in Parkinson's disease. The Movement Disorders Center (MDC) at Washington University School of Medicine has participated in over 20 clinical trials in Parkinson's disease; nine of these trials were with untreated subjects. As the only academic movement disorder program within a 200 mile radius, the MDC has an extensive primary care referral base necessary to recruit a large number of de novo patients. Initial study recruitment will occur from within the MDC clinical practice. In addition, we will utilize the Greater St. Louis Chapter of the American Parkinson Disease Association (APDA) and the APDA information and referral service to identify newly diagnosed subjects. Other recruitment strategies will include local TV, radio, and print media, web-based advertisements, and free Parkinson's Disease screenings. We propose that the study pilot phase include investigation of the validity and accuracy of electronic data entry using either a web-based or local system. The MDC has pioneered the development of an electronic medical record directly applicable to clinical practice and research studies in movement disorders. In addition, we propose that during the pilot phase of the study, a biomarker such as [18F]FDOPA PET undergo necessary validation to determine if the study medication interferes with uptake of the biomarker. If a biomarker proves to be unaffected by the study medication and meets other criteria proposed in this application, the biomarker could be used to assess disease progression in a sub-set of study subjects. The MDC at Washington University School of Medicine provides the breadth of clinical and basic research experience required to be a productive site in this large, multi-center neuroprotective trial in PD.

描述（由申请人提供）：本申请的目的是与协调中心，生物统计学中心，Ninds计划Oversite Group和41个研究站点合作，以实施大型多中心对照临床试验。在这项试验中，我们建议在帕金森氏病进行神经保护试验期间招募，注册和评估84名受试者。华盛顿大学医学院的运动障碍中心（MDC）参加了20多个帕金森氏病临床试验。这些试验中的九个是未经治疗的受试者。作为200英里半径内唯一的学术运动障碍计划，MDC拥有招募大量从头患者所需的广泛的初级保健转诊基础。最初的研究招募将从MDC临床实践中发生。此外，我们将利用美国帕金森氏病协会（APDA）的大圣路易斯分会和APDA信息和推荐服务来识别新诊断的受试者。其他招聘策略将包括本地电视，广播和印刷媒体，基于网络的广告以及免费的帕金森氏病筛查。我们建议研究试点阶段包括使用基于Web或本地系统的电子数据输入的有效性和准确性的研究。 MDC率先开发了直接适用于运动障碍临床实践和研究研究的电子病历。此外，我们建议在研究的试验阶段，[18F] FDOPA PET等生物标志物经过必要的验证，以确定研究药物是否干扰了摄取生物标志物。如果事实证明生物标志物不受研究药物的影响并符合本应用中提出的其他标准，则该生物标志物可用于评估研究对象子集中的疾病进展。华盛顿大学医学院的MDC提供了在PD这项大型多中心神经保护试验中成为富有生产力的临床和基础研究经验的广度。