Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- Drug: [18F] GE-180
- Registration Number
- NCT02559869
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Controls [18F] GE-180 Subjects with no known neurological disorder. Amyotrophic Lateral Sclerosis (ALS) [18F] GE-180 Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS.
- Primary Outcome Measures
Name Time Method Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging. 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 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. 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.
- Secondary Outcome Measures
Name Time Method Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression. 12 months Clinical and \[18F\] GE-180 PET imaging data will be collected every 6 months from the 25 people with ALS for at least 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 Clinical and MRI data will be collected every 3 months from 50 people with ALS for at least 12 months.
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States