Parkinson's Disease Neuroprotection Trial

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。

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.