Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ For participants with ALS:
• \< 36 months since onset of symptoms
• Definite, probable, lab supported-probable or possible ALS by El Escorial criteria OR definite, probable or possible ALS per Awaji-Shima Criteria
• Forced vital capacity within the last 90 days ≥ 60% of the predicted value
• Able to consent for themselves
• Able to read and speak English
• Clear of any contraindications for MRI
Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Illinois
Northwestern University
NOT_YET_RECRUITING
Evanston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Melisa Bailey, MS
baile807@umn.edu
612-624-4911
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 90
Treatments
Participants with ALS
Adults with early stage ALS
Participants without ALS
Control participants free from neurological disease
Related Therapeutic Areas
Sponsors
Collaborators: Minnesota Office of Higher Education, Food and Drug Administration (FDA)
Leads: University of Minnesota