MULTICENTER STUDY OF COQ10 & GPI 1485 IN EARLY UNTREATED PARKINSON'S DISEASE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的主要目的是评估辅酶q10和GPI 1485对帕金森病进展的影响，以评估是否继续进行这些药物的进一步研究是非徒劳的。PD的进展将通过基线访问和第12个月之间的UPDRS总分的变化来衡量，或者是残疾程度足以需要对症治疗的时间（受试者进行对症治疗前的最后一次访问），以先发生者为准。这是一项多中心、双盲、试点研究，研究对象是早期未经治疗的PD门诊患者。新生受试者将被随机分配到三个研究组中的一个：(1)接受活性CoQ10和GPI 1485安慰剂的组，(2)接受活性GPI 1485和CoQ10安慰剂的组，以及(3)接受CoQ10和GPI 1485安慰剂的组。受试者将继续使用盲法研究药物12个月。每种药物的主要比较是与历史对照数据进行比较，但为了确定同时控制率，还包括安慰剂组。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of the study is to assess the impact of CoQ10 and GPI 1485 on the progression of PD in order to assess whether it is non-futile to proceed with further study of these agents. The progression of PD will be measured by the change in total UPDRS score between the baseline visit and month 12 or the time of sufficient disability to require symptomatic therapy (last visit before subject goes on symptomatic therapy), whichever occurs first. This is a multicenter, double-blind, pilot study of outpatients with early, untreated PD. De novo subjects will be equally randomized to one of the three study arms: (1) the group that receives active CoQ10 and placebo for GPI 1485, (2) the group that receives active GPI 1485 and placebo for CoQ10 and (3) the group that receives placebo for CoQ10 and GPI 1485. Subjects will remain on blinded study drug for 12 months. The primary comparison of each drug is to historical control data, but a placebo group is included in order to ascertain concurrent control rates.