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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项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，以评估继续对这些药物进行进一步研究是否没有用处。帕金森病的进展将通过基线就诊至第12个月之间的UPDRS总分的变化或需要对症治疗的足够残疾的时间(受试者接受对症治疗前的最后一次就诊)来衡量，以较早发生的为准。这是一项针对未经治疗的早期帕金森病门诊患者的多中心、双盲、先导性研究。从头开始的受试者将被同样随机分成三组：(1)服用活性辅酶Q10和GPI 1485安慰剂的组，(2)服用活性辅酶Q10和辅酶Q10安慰剂的组，以及(3)服用辅酶Q10和GPI 1485安慰剂的组。受试者将继续服用盲法研究药物12个月。每种药物的主要比较是与历史对照数据，但包括安慰剂组，以确定同时控制率。