Continuation of NET-PD Trials at The Parkinson's Institute

描述（由申请人提供）：帕金森研究所作为NET-PD项目的临床中心之一，在过去的两个资助期内参与了NET-PD项目。目前正在进行的LS-1试验是一项多中心、双盲研究的一部分，旨在确定肌酸是否比安慰剂更有效地减缓帕金森病（PD）早期治疗患者的临床衰退。帕金森研究所已经招募了41名受试者进行LS-1试验，30名受试者仍在完成随访。主要的结果将是一个全球性的措施，包括多方面的残疾，由于PD。假设是，与安慰剂相比，每天10克肌酸与5年后疾病进展较少有关。次要假设是肌酸治疗组将有更大的疗效和类似的安全性和耐受性安慰剂。帕金森研究所的具体目标将

DESCRIPTION (provided by applicant): The Parkinson's Institute has participated as one of the clinical centers in the NET-PD program during the last two funding periods. The current LS-1 trial underway is part of a multi-center, double-blind, study to determine if creatine is more effective than placebo in slowing the clinical decline in Parkinson's disease (PD) patients with early, treated PD. The Parkinson's Institute has enrolled 41 subjects into LS-1 trial and 30 subjects are still completing follow-up visits. The primary outcome will be a global measure incorporating multiple dimensions of disability due to PD. The hypothesis is that creatine 10 grams daily will be associated with less disease progression after 5 years, when compared to placebo. Secondary hypotheses are that the creatine-treated group will have greater efficacy and similar safety and tolerability to placebo. The specific aims of the Parkinson's Institute will be (1) to continue follow-up of all active patients according to the study protocol, using good clinical practices, (2) to focus on retention of all subjects, being mindful of changing needs of patients and caregivers as the study progresses and (3) to provide high quality clinical data in a timely manner. These aims are essential to the accurate and efficient analysis of study data, testing the study hypotheses. The long track record of excellence in clinical research at the Parkinson's Institute will be the foundation of our effort. Successful completion of the LSI will address a critical gap in the treatment of Parkinson's disease, since no intervention has unequivocally been proven to slow progression of PD. As the burden of disease increases worldwide, this becomes a critical public health concern.