Effects of Coenzyme Q10 in Parkinson Disease-Phase 3

辅酶 Q10 对帕金森病 3 期的影响

• 批准号: 6966285
• 负责人: M FLINT BEAL
• 金额: $ 220.66万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6966285
• 关键词: Parkinson' s disease; brain disorder chemotherapy; chemoprevention; clinical research; clinical trial phase III; cooperative study; disease /disorder onset; drug screening /evaluation; human subject; human therapy evaluation; patient oriented research; ubiquinone

DESCRIPTION (provided by applicant): 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, and 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.

描述（由申请人提供）：帕金森病 (PD) 是一种进行性神经退行性疾病，影响超过 1,000,000 名美国人。在 NIH 支持的一项 II 期试验中，我们的团队证明，用高剂量辅酶 Q10（300、600 和 1200 mg/d）治疗早期未经治疗的 PD 患者是安全且耐受性良好的，并且有积极的趋势治疗以减缓按照统一帕金森病评定量表（UPDRS）测量的进行性损伤。在预先指定的二次分析中，我们注意到辅酶 Q10 的最高剂量是最有效的剂量，并且根据施瓦布和英格兰量表测量，辅酶 Q10 治疗有助于 PD 患者保持独立性。在拟议的研究中，我们将进行辅酶 Q10 的前瞻性、随机、安慰剂对照、双盲期临床试验，以试图确认和扩展我们 II 期研究的结果。我们建议招募 600 名早期 PD 且尚不需要多巴胺能药物治疗的受试者。受试者将被随机分配接受安慰剂、辅酶 Q10 1200 mg/d 或 2400 mg/d，在筛选、基线、第 1、4、8、12 和 16 个月就诊时进行评估，并使用 UPDRS 进行评估。研究者将确定受试者是否已经达到需要用多巴胺能药物治疗的残疾程度。我们的主要分析将通过分析 UPDRS 总分的变化来确认我们的 II 期研究中发现的益处，直到受试者达到需要多巴胺能药物治疗的残疾程度或到 16 个月的访视为止。我们还将分析收集到的 Schwab 和 England 量表以及 PD 生活质量量表数据，直至受试者达到需要多巴胺能药物治疗的残疾程度或到 16 个月的访视为止。我们将确定基线以及第 1、8 和 16 个月就诊时的平均血浆辅酶 Q10 水平，并确定该平均值是否与 UPDRS 总评分恶化的减少相关。