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制定治疗策略，以减缓或预防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，在北美和欧盟影响着超过100万人。作为确定此类疗法的第一步，NINDS在帕金森病（NET-PD）网络中的探索性试验成功地完成了徒劳的研究，该研究确定肌酸是减缓帕金森病临床衰退的潜在药物。NET-PD网络目前正在进行一项大型、长期的3期试验（称为LS1），比较肌酸和安慰剂。我们的172号站点是进行LS1试验的50个NET-PD中心之一。在这次更新中，我们计划继续在我们的中心执行试验，加强对入组受试者的保留，并完成对所有入组受试者的评估。所有的受试者都被招募，主要的努力是为了提高保留率，以检验每日给药肌酸的主要假设

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.