MINOCYCLINE AMP; CREATINE IN EARLY UNTREATED PARKINSON'S DISEASE

米诺环素安培；

• 批准号: 7378573
• 负责人: ROBERT W HAMILL
• 金额: $ 0.27万
• 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/7378573
• 关键词: antibacterial agents; placebos; tetracyclines

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.

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。该研究的主要目的是评估二甲胺四环素和肌酸对帕金森病（PD）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的进展将通过基线就诊和第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（受试者接受多巴胺能治疗前的最后一次就诊），以先发生者为准。这是一项多中心、双盲、无效的研究，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)有效的二甲胺四环素和肌酸安慰剂，(2)有效的肌酸和二甲胺四环素安慰剂，(3)二甲胺四环素和肌酸安慰剂。受试者将继续使用盲法研究药物18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。