Parkinson's Disease Neuroprotection Clinical Trial

帕金森病神经保护临床试验

• 批准号: 6545839
• 负责人: MICHAEL Jeffrey AMINOFF
• 金额: $ 11.07万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-15 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6545839
• 关键词: Parkinson's disease; antiinflammatory agents; chemoprevention; clinical research; clinical trials; cooperative study; human subject; human therapy evaluation; nervous system disorder therapy; neuropharmacology; neuroprotectants; patient oriented research

DESCRIPTION (provided by applicant): Parkinson's disease (PD) is the second most common neurodegenerative disorder. While a number symptomatic therapies have been developed, no treatment has been identified that halts or slows this progressive disorder. For a number of reasons, we believe that it is appropriate to begin a prospective clinical trial of one or more of the more promising agents to determine whether they offer benefit. The aim of this application is to participate as a clinical center in a collaborative study of neuroprotective agents. The agents and protocol will be specified by NINDS. UCSF has a long history in providing subspecialty care for subjects with PD. The UCSF Parkinson's Disease Clinic & Research Center (PDCRQ has been involved in a number of clinical trials to elucidate the neurologic dysfunction underlying PD as well as testing a variety of novel treatments for PD. This research has included a number of industry sponsored treatment trials for subjects with early to advanced PD. A large diverse, local population provides a reliable source of motivated subjects for clinical research. The experience of the UCSF PDCRC in evaluating, selecting and following subjects with PD make it an ideal candidate for a multicenter, prospective trial of a potential neuroprotectant therapy. The ideal neuroprotective treatment should be effective, inexpensive, well tolerated, safe, easy to administer, and have few interactions with common medications. A number of studies over the last decade 'in humans and experimental animals have demonstrated a local immunologic response mediated by microglia and a number of inflammatory cytokines. Moreover, several animal models of PD have demonstrated that anti-inflammatory medications can interfere with the local immunologic response, and that they may preserve function of dopaminergic neurons. Although emerging understanding of the pathogenesis of PD may provide an alternative candidate for a neuroprotectant therapy, we propose that an anti-inflammatory medication would be a rational and practical candidate for the Parkinson's disease Neuroprotection Trial.

描述（由申请人提供）：帕金森病（PD）是第二常见的神经退行性疾病。虽然已经开发了许多对症疗法，但尚未发现任何治疗方法可以阻止或减缓这种进行性疾病。出于多种原因，我们认为，开始对一种或多种更有前景的药物进行前瞻性临床试验以确定它们是否具有益处是适当的。该应用程序的目的是作为临床中心参与神经保护剂的合作研究。代理和协议将由 NINDS 指定。 UCSF 在为 PD 患者提供亚专科护理方面拥有悠久的历史。加州大学旧金山分校帕金森病临床和研究中心 (PDCRQ) 参与了许多临床试验，以阐明帕金森病潜在的神经功能障碍，并测试了各种新的帕金森病治疗方法。这项研究包括许多行业赞助的针对早期至晚期帕金森病受试者的治疗试验。大量多样化的当地人群为临床研究提供了可靠的积极受试者来源。 UCSF PDCRC 在评估、选择和跟踪 PD 受试者方面使其成为潜在神经保护疗法多中心前瞻性试验的理想候选者。 理想的神经保护治疗应该有效、廉价、耐受性好、安全、易于管理，并且与常用药物几乎没有相互作用。过去十年在人类和实验动物中进行的多项研究表明，小胶质细胞和多种炎症细胞因子介导局部免疫反应。此外，一些帕金森病动物模型已经证明，抗炎药物可以干扰局部免疫反应，并且可以保留多巴胺能神经元的功能。尽管对帕金森病发病机制的新认识可能为神经保护剂治疗提供替代候选药物，但我们建议抗炎药物将是帕金森病神经保护试验的合理且实用的候选药物。