PARKINSON DISEASE NEUROPROTECTIVE TRIAL:CLINICAL CENTER

帕金森病神经保护试验：临床中心

• 批准号: 6545852
• 负责人: Brad A Racette
• 金额: $ 11.25万
• 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 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6545852
• 关键词: Parkinson's disease; biomarker; chemoprevention; clinical research; clinical trials; cooperative study; human subject; human therapy evaluation; medical outreach /case finding; nervous system disorder therapy; neuroprotectants; patient oriented research; positron emission tomography

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）：本申请的目标是与协调中心、生物统计中心、NINDS 项目现场小组和遍布美国的 41 个研究中心合作，实施一项大型、多中心对照临床试验。在这项试验中，我们建议在进行帕金森病神经保护试验期间招募、入组和评估 84 名受试者。华盛顿大学医学院运动障碍中心 (MDC) 参与了 20 多项帕金森病临床试验；其中九项试验是针对未经治疗的受试者。作为 200 英里半径内唯一的学术运动障碍项目，MDC 拥有广泛的初级保健转诊基础，可以招募大量新发患者。最初的研究招募将从 MDC 临床实践中进行。此外，我们将利用美国帕金森病协会 (APDA) 大圣路易斯分会以及 APDA 信息和转诊服务来识别新诊断的受试者。其他招募策略将包括当地电视、广播和印刷媒体、网络广告以及免费帕金森病筛查。我们建议研究试点阶段包括调查使用基于网络或本地系统的电子数据输入的有效性和准确性。 MDC 率先开发了直接适用于运动障碍临床实践和研究的电子病历。此外，我们建议在研究的试点阶段，对[18F]FDOPA PET等生物标志物进行必要的验证，以确定研究药物是否会干扰生物标志物的摄取。如果生物标志物被证明不受研究药物的影响并且满足本申请中提出的其他标准，则该生物标志物可用于评估研究受试者子集的疾病进展。华盛顿大学医学院的 MDC 提供了成为这一大型多中心 PD 神经保护试验的富有成效的场所所需的广泛的临床和基础研究经验。