NEUROPROTECTION EXPLORATORY TRIALS IN PD (NET-PD)

描述（由申请人提供）：神经科学界的一个主要目标是开发治疗策略，减缓或阻止慢性神经退行性疾病的进展。帕金森病（PD）是最常见的成人神经退行性疾病之一，在北美和欧盟影响超过100万人。作为确定此类疗法的第一步，NINDS帕金森病探索性试验（NET-PD）网络成功完成了无效研究，该研究将肌酸确定为减缓PD临床下降的潜在药物。NET-PD网络目前正在进行一项大型，长期的3期试验（称为LS 1），比较肌酸和安慰剂。我们的研究中心#172是开展LS 1试验的50家NET-PD中心之一。在本次更新中，我们计划继续在我中心执行试验，加强入组受试者的保留，并完成对我中心入组的所有受试者的评价。所有受试者都被招募，主要的努力是提高记忆力，以检验主要假设，即每日给予肌酸（10 在多巴胺能治疗和最佳PD护理的背景下，在减缓基线和5年随访访视之间PD的临床下降方面，此外，还将评估肌酸对个体PD指标有效性的次要指标。我们已采取措施，以提高保留以下统一的指导方针，从临床协调中心。此外，我们还制定了针对我们工厂人口的战略。迄今为止，这些措施成功地保留了超过5年试验的受试者。

DESCRIPTION (provided by applicant): A major goal of the neuroscience community is to develop treatment strategies that will slow or forestall the progression of chronic neurodegenerative diseases. Parkinson's disease (PD) is one of the most common adult neurodegenerative disorders, affecting over 1 million people in North America and the European Union. As a first step in identifying such therapies, the NINDS Exploratory Trials in Parkinson's disease (NET-PD) network successfully completed futility studies, which identified creatine as a potential agent to slow clinical decline in PD. The NET-PD network is now conducting a large, long-term, Phase 3 trial (known as LS1) comparing creatine to placebo. Our site #172 is one of the 50 NET-PD centers conducting the LS1 trial. In this renewal, we plan on continuing the execution of the trial at our center, enhance retention of enrolled subjects and complete the evaluations of all subjects enrolled at our site. All subjects are enrolled and the major effort isto enhance retention in order to test the primary hypothesis that daily administration of creatine (10 gm/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. In addition, secondary measures of efficacy of creatine on individual PD measures will be assessed. We have implemented measures to enhance retention following uniform guidelines from the Clinical Coordinating Center. In addition, we have developed strategies that target the population at our site. These measures have been so far successful in retaining subjects past the 5 years of the trial.