Emory University PD Neuroprotection Clinical Trial Center

埃默里大学 PD 神经保护临床试验中心

• 批准号: 7233699
• 负责人: JORGE L JUNCOS
• 金额: $ 7.23万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-17 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7233699
• 关键词: Affect; Agreement; Alabama; American; Animal Model; Apoptosis; Area; Biological Markers; Brain; Cell Death; Cells; Certification; Characteristics; Clinic; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Coenzyme Q10; Commit; Conduct Clinical Trials; Confidentiality; Contracts; Data; Data Collection; Diagnosis; Disease; Disease Association; Disease Progression; Documentation; Dopamine; Double-Blind Method; Excitatory Amino Acid Antagonists; Futility; Goals; In Vitro; Methods; Monitoring Clinical Trials; Motor; Movement Disorders; Neurodegenerative Disorders; Newly Diagnosed; Numbers; Parkinson Disease; Participant; Patient Recruitments; Patients; Peripheral; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Pilot Projects; Population Heterogeneity; Population Study; Principal Investigator; Process; Property; Purpose; Randomized; Recruitment Activity; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Resources; Review Committee; Safety; Secondary Parkinson Disease; Series; Site; Specimen; Symptoms; Testing; Thinking; Time; Training; USA Georgia; United States National Institutes of Health; Universities; Western Asia Georgia; Work; base; dopaminergic neuron; experience; neuron loss; neuroprotection; preclinical study; programs; response

DESCRIPTION (provided by applicant): The Emory University Movement Disorders Program and the Comprehensive Parkinson's Disease Center has proven to have in place the necessary resources and infrastructure to continue to be a Parkinson's Disease Neuroprotection Clinical Trial Center. We have experience in conducting neuroprotective trials and are in fact already participating in the NET-PD Futility Study 2 trial as a subcontractor to University of Alabama in Birmingham (UAB). The aim of this proposal in to revert our center from a subcontracting site to its original status as an independent site. We have been a successful site in this and many other studies in part because of the estimated 50,000 persons currently diagnosed with Parkinson's disease in our region and the estimated 5,000 patients that are newly diagnosed each year in our region. The demographic characteristics of the area served by Emory University allows for the recruitment of an ethnically diverse population of study patients. The Emory University programs involved in the research and treatment of Parkinson's Disease have the necessary space to comfortably and efficiently conduct clinical trials, prepare and process lab specimens and securely and confidentially maintain study medication and documentation. An experienced clinical trial team is currently in place to assure that the studies are conducted in a manner which allows for the accurate, efficient and timely collection of data. The Clinical Trial Staff have all received training and certification to conduct clinical trials from the Emory University Institutional Review Board and have been trained and currently follow Good Clinical Practice Guidelines to assure the safety and protection of study participants. The Principal Investigator, Dr. Jorge L. Juncos, has extensive experience in developing, conducting and monitoring clinical trials and an excellent track record in the recruitment of patients. The Center currently works closely with the American Parkinson Disease Association of Georgia to inform and recruit new patients for these studies. In conclusion this proposal should evidence the fact that our center has demonstrated is capacity for serving as an excellent investigative and recruitment site for these NIH sponsored trials in neuroprotection in PD.

描述（由申请人提供）：埃默里大学运动障碍项目和综合帕金森病中心已证明拥有必要的资源和基础设施，可以继续成为帕金森病神经保护临床试验中心。我们在进行神经保护试验方面拥有丰富的经验，并且实际上已经作为伯明翰阿拉巴马大学 (UAB) 的分包商参与了 NET-PD Futility Study 2 试验。该提案的目的是将我们的中心从分包地点恢复为独立地点的原始状态。我们在这项研究和许多其他研究中取得了成功，部分原因是我们地区目前估计有 50,000 人被诊断患有帕金森病，并且我们地区每年估计有 5,000 名新诊断的患者。埃默里大学服务地区的人口特征允许招募不同种族的研究患者。埃默里大学参与帕金森病研究和治疗的项目拥有必要的空间，可以轻松高效地进行临床试验、准备和处理实验室标本以及安全保密地保存研究药物和文件。目前，一支经验丰富的临床试验团队已就位，以确保研究的进行能够准确、高效和及时地收集数据。临床试验人员均已接受埃默里大学机构审查委员会颁发的进行临床试验的培训和认证，并接受过培训，目前遵循良好临床实践指南，以确保研究参与者的安全和保护。首席研究员 Jorge L. Juncos 博士在开发、实施和监测临床试验方面拥有丰富的经验，并且在患者招募方面拥有出色的记录。该中心目前与佐治亚州美国帕金森病协会密切合作，为这些研究提供信息并招募新患者。总之，该提案应证明我们的中心已经证明有能力作为 NIH 资助的 PD 神经保护试验的优秀研究和招募场所。