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

COQ10 的多中心研究

• 批准号: 7378581
• 负责人: ROBERT W HAMILL
• 金额: $ 0.32万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-09 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378581
• 关键词: placebos

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。该研究的主要目的是评估CoQ 10和GPI 1485对PD进展的影响，以评估继续对这些药物进行进一步研究是否是徒劳的。PD的进展将通过基线访视与第12个月之间的总AERS评分的变化或残疾程度足以需要对症治疗的时间（受试者接受对症治疗前的末次访视）（以先发生者为准）来衡量。 这是一项在早期未经治疗的PD门诊患者中进行的多中心、双盲、初步研究。初治受试者将被平等随机分配至三个研究组之一：（1）接受活性辅酶Q10和GPI 1485安慰剂的组，（2）接受活性GPI 1485和辅酶Q10安慰剂的组，（3）接受辅酶Q10和GPI 1485安慰剂的组。受试者将继续接受设盲研究药物治疗12个月。每种药物的主要比较是与历史对照数据进行比较，但包括安慰剂组以确定并行控制率。