Parkinson's Disease Neuroprotection Clinical Trial

描述(申请人提供)：帕金森病(PD)是第二种最常见的神经退行性疾病。虽然已经开发了一些对症治疗方法，但还没有确定可以阻止或减缓这种进行性疾病的治疗方法。由于许多原因，我们认为，对一种或多种前景更好的药物进行前瞻性临床试验是合适的，以确定它们是否提供益处。这项申请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。 加州大学旧金山分校在为帕金森病患者提供专科护理方面有很长的历史。加州大学旧金山分校帕金森氏病临床与研究中心(PDCRQ)参与了一系列临床试验，以阐明帕金森病潜在的神经功能障碍，并测试各种治疗帕金森病的新疗法。这项研究包括了一些针对早期到晚期帕金森病患者的行业赞助的治疗试验。庞大多样的当地人口为临床研究提供了一个有动力的研究对象的可靠来源。加州大学旧金山分校PDCRC在评估、选择和跟踪PD受试者方面的经验使其成为潜在神经保护疗法的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是有效的、廉价的、耐受性好的、安全的、易于管理的，并且与普通药物几乎没有相互作用。在过去的十年里，在人类和实验动物上的许多研究已经证明了由小胶质细胞和一些炎性细胞因子介导的局部免疫反应。此外，几个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，它们可以保护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治疗提供了一种替代方案，但我们认为抗炎药物将是帕金森病神经保护试验的合理和实用的候选药物。

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.