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Parkinson's Disease Neuroprotection Trial

帕金森病神经保护试验

基本信息

批准号：
8601131
负责人：
JULIE H CARTER
金额：
$ 5.51万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
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/8601131
关键词：
Activities of Daily Living Address Adult Affect American Award Caring Chronic Clinical Clinical Trials Coenzyme Q10 Communities Creatine Diagnosis Digit structure Disease Disease Progression Dose Double-Blind Method England Enrollment European Union Evaluation Futility Goals Health Health Care Costs Health Services Individual Levodopa Maintenance Measures Mental Depression Minocycline Modality Morbidity - disease rate National Institute of Neurological Disorders and Stroke Neurodegenerative Disorders Neurosciences North America Outcome Measure Parkinson Disease Participant Phase Phase III Clinical Trials Placebos Prevention Prevention therapy Quality of life Recording of previous events Research Safety Testing Therapeutic Therapeutic Equivalency United States Visit burden of illness cognitive function design disability follow-up mortality neuroprotection operation primary outcome programs treatment strategy

项目摘要

DESCRIPTION (provided by applicant): The NET-PD program used a rational, scientific approach for the selection and evaluation of potential therapies for the prevention of Parkinson's disease (PD) progression. Since its original award, the NET-PD program has successfully completed two futility studies, known as Futility Study 1 (FS-1) and Futility Study 2 (FS-TOO) which evaluated the therapeutic potential of four compounds (creatine, minocycline, coenzyme Q10 (CoQ10), and GPI-1485) [5, 6]. The results of FS-1 and FS-TOO informed the design of a large, simple clinical trial for efficacy of creatine treatment in slowing clinical decline in participants with early, treated Parkinson's disease, known as LS1. LS1 is a multi-center. Phase 3, double-blind clinical trial of creatine for the prevention of PD progression that tests the hypothesis that daily administration of creatine (10gm/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5 year follow-up visit against the background of dopaminergic therapy and best PD care.

描述（由申请方提供）：NET-PD项目采用合理、科学的方法选择和评价预防帕金森病（PD）进展的潜在疗法。自最初授予以来，NET-PD计划已成功完成了两项无效研究，称为无效研究1（FS-1）和无效研究2（FS-TOO），评估了四种化合物（肌酸，米诺环素，辅酶Q10（CoQ 10）和GPI-1485）的治疗潜力[5，6]。FS-1和FS-TOO的结果为一项大型、简单的临床试验的设计提供了信息，该试验旨在研究肌酸治疗在减缓早期接受治疗的帕金森病患者（称为LS 1）临床下降方面的疗效。LS 1是一个多中心。一项肌酸预防PD进展的III期、双盲临床试验，旨在检验以下假设：在多巴胺能治疗和最佳PD护理的背景下，肌酸每日给药（10 gm/天）在减缓基线和5年随访访视之间的PD临床下降方面比安慰剂更有效。