Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging.
研究概览
简要总结
This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.
详细描述
In this trial, approximately 200 subjects will participate in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and gender matched to 50 participants with no known neurological disorder (healthy controls). Of these, twenty five (25) ALS participants will be age (±5 years) gender and binding affinity (TSPO) matched to 25 healthy controls.
During the enrollment period 200 participants will be screened and 100 participants will ultimately be scanned. There will be a maximum allowed time of 45 days between the screening and baseline visits (1st scan). All 100 subjects will undergo MRI scanning and clinical assessment at the Baseline Visit. Healthy control participants will have no further follow-up visits once they have completed their participation in the screening and baseline visits. Only 50 subjects from this sample will undergo PET scanning. The ALS participants will return for follow-up MRI scanning and clinical assessments every three months and follow-up PET scanning every 6 months over a 12-month period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Amyotrophic Lateral Sclerosis (ALS)
Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS.
干预措施: [18F] GE-180 (Drug)
Healthy Controls
Subjects with no known neurological disorder.
干预措施: [18F] GE-180 (Drug)
结局指标
主要结局
Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging.
时间窗: 12 months
Aim 1 will be accomplished by obtaining \[18F\] GE-180 PET imaging from 25 people with ALS compared to 25 age, gender, and binding affinity matched healthy volunteers.
Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline
时间窗: 12 months
Aim 1 will be accomplished by obtaining state of-the-art MRI acquisition sequences from 50 people with ALS compared to 50 MRI age- and gender-matched healthy volunteers.
Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS.
时间窗: 12 months
Blood from 100 subjects will be studied to quantitate circulating pro- and anti-inflammatory monocyte/macrophage and T cells, with results to be correlated with neuroimaging and evaluated as potential biomarkers of disease progression.
次要结局
- Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression.(12 months)
- Determine the longitudinal changes in the anatomical, structural, and functional measures in people with ALS, and build ALS prediction models using the clinical and MRI data.(12 months)
研究者
Suma Babu
Co-Principal Investigator
Massachusetts General Hospital