MINOCYCLINE AMP; CREATINE IN EARLY UNTREATED PARKINSON'S DISEASE

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米诺环素和肌酸对帕金森病(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没有意义。帕金森病的进展将通过基线就诊到第12个月之间的UPDRS总评分的变化或需要对症治疗的足够残疾的时间(受试者接受多巴胺能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、徒劳研究。新手受试者将被随机分为三组：(1)肌酸的活性米诺环素和安慰剂，(2)米诺环素的活性肌酸和安慰剂，以及(3)米诺环素和肌酸的安慰剂。受试者将继续接受18个月的盲法研究药物。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。

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 minocycline and creatine on the progression of Parkinson's Disease (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 dopaminergic therapy), whichever occurs first. This is a multicenter, double-blind, futility study of outpatients with early, untreated PD. De novo subjects will be equally randomized to one of the three study arms: (1) active minocycline and placebo for creatine, (2) active creatine and placebo for minocycline, and (3) placebo for minocycline and creatine. Subjects will remain on blinded study drug for 18 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.