Multicenter ALS Imaging Study
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Minnesota
- Study ID
- NCT06735014
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Magnetic Resonance Imaging — DIAGNOSTIC_TESTParticipants will undergo 3T MRI scanning of the brain and cervical spine MRIs
- Plasma neurofilament light chain (NfL) quantification — DIAGNOSTIC_TESTParticipants will undergo a blood draw for the quantification of plasma neurofilament light chain
Study Details
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.
Key Dates
- Start date
- Sep 15, 2024
- Status verified
- May 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 90 participants (estimated)
Arms
- Arm: Participants with ALSAdults with early stage ALS
- Arm: Participants without ALSControl participants free from neurological disease
Primary Outcome Measure
Fiber Density [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
Central Contacts
- Melisa Bailey, MS612-624-4911
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | Jennifer Steshyn, MABMH, CCRP James Wymer, MD, FAAN (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Evanston | Illinois | 60208 | Emma Schmidt Senda Ajroud-Driss, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Melisa Bailey, MS David Walk, MD (PRINCIPAL_INVESTIGATOR) |
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