Parkinson's Disease Neuroprotection Trial

描述（由申请人提供）：NET-PD项目采用合理、科学的方法来选择和评估预防帕金森病（PD）进展的潜在疗法。自最初获奖以来，NET-PD项目已经成功完成了两项无效研究，即无效研究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 （CoQ10）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依据，该试验旨在研究肌酸治疗对早期治疗过的帕金森病（LS1）患者临床衰退的减缓效果。LS1是一个多中心。3期，肌酸预防PD进展的双盲临床试验，验证了在多巴胺能治疗和最佳PD护理的背景下，从基线到5年随访期间，每日服用肌酸（10gm/天）在减缓PD临床下降方面比安慰剂更有效的假设。

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.