NCT03034122已完成不适用
Is Caffeine an Environmental Modifier in Huntington's Disease?
University Hospital, Lille10 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年10月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Change in striatal volume
研究概览
简要总结
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HD mutation carriers (>36 CAG)
- •premanifest (total motor UHDRS < 5)
- •estimated time to diagnosis between 3 and 10 years
- •adults older than 21 years (in order to exclude juvenile patients who begin the disease before 21 years)
- •informed consent signed
- •with a social protection
排除标准
- •MRI contraindication
- •pregnant and lactating women
- •People under guardianship, trusteeship, deprive of freedom
结局指标
主要结局
Change in striatal volume
时间窗: at 2 years
次要结局
- Unified Huntington's Disease Rating Scale (UHDRS)(at 1 years, at 2 years)
- PBA (problem behaviors assessment)(at 1 years, at 2 years)
- Stroop test(at 1 years, at 2 years)
- score at Epworth sleepiness scale(at 1 years, at 2 years)
- SDMT -symbol digit modality test(at 1 years, at 2 years)
- MRI(at 1 years, at 2 years)
研究者
研究点 (10)
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