Continuation of NET-PD Trials at Indiana University

印第安纳大学继续进行 NET-PD 试验

• 批准号: 8460248
• 负责人: JOANNE M WOJCIESZEK
• 金额: $ 1.56万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8460248
• 关键词: Activities of Daily Living; Adult; Adverse effects; Affect; Caring; Chronic; Clinical; Clinical Trials; Clinical Trials Design; Cognitive; Communities; Creatine; Critiques; Data Coordinating Center; Digit structure; Disease; Dose; Double-Blind Method; England; Enrollment; European Union; Evaluation; Futility; Goals; Health Services; Indiana; Individual; Levodopa; Maintenance; Measures; Mental Depression; Modality; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; Neurosciences; New Agents; North America; Outcome Measure; Parkinson Disease; Participant; Patients; Phase III Clinical Trials; Pilot Projects; Placebos; Principal Investigator; Quality of life; Reporting; Role; Safety; Series; Study Section; Testing; Therapeutic Equivalency; Universities; Update; Visit; Writing; base; clinical research site; cognitive function; design; disability; follow-up; meetings; operation; primary outcome; public health relevance; treatment strategy

DESCRIPTION (provided by applicant): This application is for the continuation of a NET-PD clinical site at Indiana University. 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 trials; to reportdata 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 showing the clinical decline in PD patients with early treated PD. The primary objective of the study is to determine if there is a slowing of clinical decline in PD subjects defined by a combination of cognitive, physical, and quality of life measures. Enrollment began in 2007 and will continue through 2015, or end of study.

描述（由申请人提供）：此申请是为了在印第安纳大学继续进行Net-PD临床站点。 NET-PD旨在让患者参加一系列试验研究和新药物治疗帕金森氏病的临床试验。角色 临床部位是在这些试验中识别，筛查，注册，治疗和关注患者；及时向数据协调中心举报；并报告注册患者的不良影响。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，旨在确定肌酸在显示早期治疗PD的PD患者的临床下降方面是否比安慰剂更有效。该研究的主要目的是确定由认知，身体和生活质量衡量标准的结合所定义的PD受试者临床下降的放缓。入学率始于2007年，将持续到2015年或研究结束。