Neuroprotective Clinical Studies in Parkinson's Disease

帕金森病的神经保护临床研究

• 批准号: 8785162
• 负责人: MARK F LEW
• 金额: $ 5.81万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 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 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8785162
• 关键词: Activities of Daily Living; Adult; Adverse effects; Affect; California; Caring; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communities; Creatine; Data; Data Coordinating Center; Data Reporting; Digit structure; Disease; Dose; Double-Blind Method; England; Enrollment; Ethnic group; European Union; Female; Futility; Future; Goals; Good Clinical Practice; Health; Health Services; Individual; Intervention; Levodopa; Maintenance; Measures; Mental Depression; Modality; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; Neurologist; Neuroprotective Agents; Neurosciences; New Agents; North America; Outcome Measure; Parkinson Disease; Participant; Patients; Phase III Clinical Trials; Pilot Projects; Placebos; Protocols documentation; Quality of life; Race; Reporting; Role; Safety; Schedule; Series; Site; Telephone; Testing; Therapeutic Equivalency; TimeLine; Transportation; Travel; Universities; Visit; clinical research site; cognitive function; design; disability; expectation; follow-up; male; meetings; operation; primary outcome; treatment strategy

DESCRIPTION (provided by applicant): This application is for the continuation of a NET PD clinical site at the University of Southern California. NET PD was designed to enroll patients in a series of pilot studies and clinical trials of new agents for the treatment of Parkinson's disease. The role of the clinical sites is to identify, screen, enroll, treat, and follow patients in these rials; to report data in a timely manner to the data coordinating center and to report adverse effects among enrolled patients. Currently, NET PD is conducting the LS-1 study, a multi-center, double-blind, phase III clinical trial designed to determine whether or not creatine is more effective than placebo in slowing the clinical decline in PD patients with early, treated PD. Enrollment began in 2007 and was completed on 5-28-10. All patients will be on treatment and followed for a minimum 5 years or until the end of the study. Additional exploratory trials in Parkinson's disease will be developed and conducted utilizing potential neuroprotective agents or combinations of agents over the next 5-year period as determined by the NET-PD study group and NINDS. The University of Southern California has completed 9 years of the LS-1 NET-PD study. The first subject enrolled into the LSI study on 4/30/07. A total of 55 subjects have been enrolled. Of the total enrolled, 3 have been lost to follow up, 3 have expired and the remaining 49 are active. The conduct of the study has been uneventful. Both Males and females from diverse ethnic and racial groups have been enrolled. Subjects are followed according to the protocol and in keeping with good clinical practices. Data is reported in a timely manner to the coordinating center. It is anticipated that future timelines and protocol expectations will be met on schedule.

描述（由申请人提供）：此申请是为了在南加州大学延续PD临床网站。净PD旨在注册患者 针对治疗帕金森氏病的新药物的一系列试点研究和临床试验。 临床部位的作用是识别，筛查，招募，治疗和关注这些rial的患者。及时向数据协调中心报告数据，并报告注册患者的不利影响。目前，NET PD正在进行LS-1研究，这是一项多中心，双盲，III期临床试验，旨在确定肌酸在减慢早期治疗PD的PD患者的临床下降方面是否比安慰剂更有效。入学率始于2007年，于5-28-10完成。所有患者将接受治疗，并至少5年或直到研究结束。帕金森氏病的其他探索性试验将在接下来的5年中使用潜在的神经保护剂或组合，并由Net-PD研究组和NINDS确定。南加州大学已经完成了9年的LS-1 Net-PD研究。第一个受试者于07年4月30日参加了LSI研究。总共有55名受试者。在招募的总数中，有3个丢失了以跟进，其中3次已过期，其余49个处于活动状态。该研究的行为很顺利。来自不同种族和种族群体的男性和女性都被招募了。根据方案并遵循良好的临床实践，遵循受试者。数据及时报告给协调中心。预计未来的时间表和协议期望将按计划满足。