Effects of Coenzyme Q10 in Parkinson Disease-Phase 3

帕金森病(PD)是一种进行性、神经退行性疾病，影响超过100万人 美国人。在一项由NIH支持的II期试验中，我们的团队证明了对早期、 大剂量辅酶Q10(300、600和1200 mg/d)治疗帕金森病安全且耐受性好 治疗有一个积极的趋势，以减缓进行性损害，由 统一帕金森病评定量表(UPDRS)。在预先指定的二次分析中，我们注意到 辅酶Q10的最大剂量是最有效的剂量，辅酶Q10的治疗效果最好 帮助帕金森病患者保持独立，采用施瓦布和英格兰量表进行评定。 在拟议的研究中，我们将进行前瞻性、随机、安慰剂对照、双盲阶段。 辅酶Q10的临床试验，试图确认和扩大我们的II期研究的结果。我们 建议招募600名早期帕金森病患者，他们还不需要多巴胺能治疗 探员们。受试者将被随机分配接受安慰剂、辅酶Q10 1200 mg/d或2400 mg/d， 在筛查、基线、1个月、4个月、8个月、12个月和16个月进行评估，并使用UPDRS进行评估。 调查员将确定受试者是否已经达到残疾，需要通过 多巴胺能药。我们的初步分析将确认在我们的第二阶段研究中发现的好处 通过分析UPDRS总分的变化到受试者达到残疾要求的程度 用多巴胺能药治疗或到16个月后复诊。 我们还将分析施瓦布和英格兰量表和PD生活质量量表收集到的数据 受试者达到残疾需要多巴胺能药物治疗的时间点或16个月的随访。 我们将在基线和随访1、8和16个月时测定平均血浆辅酶Q10水平，并 确定平均数是否与UPDRS总分恶化的减少相关。

Parkinson's Disease (PD) is a progressive, neurodegenerative disease, which affects over 1,000,000 Americans. In an NIH-supported phase II trial, our group demonstrated that treatment of patients with early, untreated PD with high dosages of coenzyme Q10 (300, 600 and 1200 mg/d) was safe and well tolerated and that there was a positive trend for treatment to slow the progressive impairment as measured by the Unified Parkinson Disease Rating Scale (UPDRS). In pre-specified secondary analyses, we noted that the highest dosage of coenzyme Q10 was the most effective dosage and that treatment with coenzyme Q10 helped the PD patients maintain independence, as measured by Schwab and England Scale. In the proposed study, we will conduct a prospective, randomized, placebo-controlled, double-blind phase clinical trial of coenzyme Q10 to attempt to confirm and extend the results of our phase II study. We propose to enroll 600 subjects who have early PD and do not yet require treatment with dopaminergic agents. Subjects will be randomly assigned to receive placebo, coenzyme Q10 1200 mg/d or 2400 mg/d, evaluated at screening, baseline, months 1, 4, 8, 12, and 16 visits and assessed with the UPDRS. The investigator will determine whether the subject has reached disability requiring treatment with a dopaminergic agent. Our primary analysis will undertake to confirm the benefit found in our phase II study by analyzing the change in total UPDRS score to the point that the subjects reach disability requiring treatment with a dopaminergic agent or to the 16 month visit. We will also analyze the Schwab and England Scale and the PD Quality of Life Scale data collected to the point that the subjects reach disability requiring treatment with a dopaminergic agent or to the 16 month visit. We will determine the mean plasma coenzyme Q10 levels at baseline and at visits 1, 8 and 16 months, and determine whether the mean correlates with reduction in worsening of the total UPDRS score.