NCT01508962进行中（未招募）不适用
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Phenoconversion
研究概览
简要总结
The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a male or female, aged at least 18 years.
- •Subject is affected with ALS (familial or sporadic).
- •Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
- •Subject is willing and able to comply with all study procedures.
- •Subject agrees to provide signed and dated informed consent form.
- •Control group:
- •Subject is a male or female, aged at least 18 years.
- •Subject is not affected with ALS or an ALS-related disorder.
- •Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
- •Subject is willing and able to comply with all study procedures.
- •Subject agrees to provide signed and dated informed consent form.
- •Exclusion Criterion
- •Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).
排除标准
- 未提供
结局指标
主要结局
Phenoconversion
时间窗: Every three months over the course of one year
次要结局
未报告次要终点
研究者
Michael Benatar
Professor of Neurology
University of Miami
研究点 (1)
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