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Parkinson's Disease Neuroprotection Clinical Trial

帕金森病神经保护临床试验

基本信息

批准号：
8601321
负责人：
MICHAEL Jeffrey AMINOFF
金额：
$ 3.8万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-15 至 2014-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8601321
关键词：
Activities of Daily Living Adult Adverse effects Affect Caring Clinical Clinical Trials Clinical Trials Design Communities Creatine Data Coordinating Center Data Reporting Data Set Digit structure Disease Disease Progression Dose Double-Blind Method England Enrollment European Union Futility Goals Health Health Care Costs Health Services Individual Levodopa Maintenance Measures Mental Depression Modality Moods Movement National Institute of Neurological Disorders and Stroke Neurodegenerative Disorders Neuroprotective Agents Neurosciences New Agents North America Outcome Measure Parkinson Disease Participant Patients Phase Phase III Clinical Trials Pilot Projects Pioglitazone Placebo Control Placebos Prevention Procedures Protocols documentation Quality of life Randomized Recruitment Activity Reporting Role Safety Series Study Subject Testing Therapeutic Equivalency Thinking Visit cognitive function design disability double-blind placebo controlled trial follow-up improved insight neuroprotection operation primary outcome prospective treatment strategy

项目摘要

DESCRIPTION (provided by applicant): Parkinson's disease (PD) is the second most common neurodegenerative disorder. While a number of 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 conduct prospective clinical trials of one or more of the more promising agents to determine whether they offer benefit. The aim of this application is for UCSF to continue participation as a clinical center in a collaborative study of neuroprotective agents. 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 sies is to identify, screen, enroll, treat, and follow patients in these trials; to report data in a timly 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 ended in May of 2010, with all patients on treatment and followed for a minimum of 5 years or up to 8 years, through May 2015. A supplemental futility trial was initiated in May 2011 and continues enrollment. The FS-ZONE trial is a randomized, double-blind placebo-controlled futility study evaluating pioglitazone for the prevention of Parkinson's disease progression. The subjects will be followed for 44 weeks.

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UCSF继续作为临床中心参与神经保护剂的合作研究。NET-PD旨在招募患者参加一系列用于治疗帕金森病的新药的试点研究和临床试验。临床研究的作用是在这些试验中识别、筛选、招募、治疗和随访患者;及时向数据协调中心报告数据;并报告招募患者的不良反应。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，旨在确定肌酸是否比安慰剂更有效地减缓早期治疗PD患者的临床下降。入组开始于2007年，结束于2010年5月，所有患者均接受治疗，并随访至少5年或长达8年，直至2015年5月。2011年5月启动了一项补充无效试验，并继续招募。FS-ZONE试验是一项随机、双盲、安慰剂对照、无效性研究，评价吡格列酮预防帕金森病进展的作用。受试者将接受44周随访。