ALS Translational Research Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- ALS Functional Rating Scale - Revised (ALSFRS-R)
研究概览
简要总结
The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •18 years of age or older
- •Can communicate in written English
- •Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation
排除标准
- •Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.
结局指标
主要结局
ALS Functional Rating Scale - Revised (ALSFRS-R)
时间窗: Monthly, through study completion, an average of 1 year
A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale.
次要结局
- Machine-Learning Based Speech Scoring(Monthly, through study completion, an average of 1 year)
- Limb-based Accelerometry(monthly, through study completion, an average of 6 months)
- Medications, Supplements, and Clinical Trial Participation Surveys(quarterly, through study completion, an average of 1 year)
- Social and Environmental Surveys(One-time or quarterly at months 1, 4, 7, 10)