Parkinson's Disease Neuroprotection Clinical 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治疗，但尚未确定停止或减缓这种进行性疾病的治疗。出于多种原因，我们认为开始对一种或多种更有前途的药物进行前瞻性临床试验以确定它们是否提供益处是合适的。本申请的目的是作为临床中心参与神经保护剂的合作研究。药物和方案将由NINDS规定。 UCSF在为PD受试者提供专科护理方面有着悠久的历史。UCSF帕金森病诊所和研究中心（PDCRQ）参与了许多临床试验，以阐明帕金森病的神经功能障碍，并测试各种新的治疗方法。本研究包括许多行业申办的针对早期至晚期PD受试者的治疗试验。一个大的多样性，当地人口提供了一个可靠的来源，积极的受试者的临床研究。UCSF PDCRC在评估、选择和随访PD受试者方面的经验使其成为潜在神经保护剂治疗的多中心、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，安全，易于管理，并与常见药物的相互作用很少。在过去的十年中，在人类和实验动物中的许多研究已经证明了由小胶质细胞和许多炎性细胞因子介导的局部免疫应答。此外，几种PD动物模型已经证明抗炎药物可以干扰局部免疫反应，并且它们可以保护多巴胺能神经元的功能。虽然对PD发病机制的新认识可能为神经保护剂治疗提供了另一种候选药物，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.