Coenzyme Q10 in Huntington’s Disease (2CARE). Homo sapiens

This is a multi-center, randomized, double-blind, placebo-controlled trial of CoQ involving 609 ambulatory subjects with HD who are not requiring skilled care or institutionalization. Eligible subjects were randomized to receive either CoQ 2400 mg/day or matching placebo. Subjects were followed prospectively and systematically for 60 months of double-blind observation. The primary outcome variable is a combination of time to death (for subjects who die) and the change from baseline to Month 60 in Total Functional Capacity (TFC) score (for subjects who survive). The primary hypothesis of the study is that chronic treatment of early-stage HD subjects with high-dosage CoQ will slow the progressive functional decline of HD.

本研究为一项多中心、随机、双盲、安慰剂对照的辅酶Q（CoQ）临床试验，共纳入609名无需专业护理或机构照料的能自主活动的亨廷顿舞蹈症（HD）受试者。合格受试者被随机分配接受每日2400mg的辅酶Q或外观匹配的安慰剂。所有受试者接受为期60个月的前瞻性系统随访，全程采用双盲观察设计。主要结局指标为联合终点：对于死亡受试者，记录其至死亡的时间；对于存活受试者，则统计其总功能能力（Total Functional Capacity, TFC）评分从基线至第60个月的变化量。本研究的主要假设为：对早期亨廷顿舞蹈症受试者采用高剂量辅酶Q进行长期治疗，可延缓该疾病的进行性功能衰退。