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_TEST
    Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs
  • Plasma neurofilament light chain (NfL) quantification — DIAGNOSTIC_TEST
    Participants 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 ALS
    Adults with early stage ALS
  • Arm: Participants without ALS
    Control participants free from neurological disease

Primary Outcome Measure

Fiber Density [ Time Frame: Baseline, 3 months, 6 months, 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Jennifer Steshyn, MABMH, CCRP
James Wymer, MD, FAAN (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityEvanstonIllinois60208
Emma Schmidt
Senda Ajroud-Driss, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Melisa Bailey, MS
David Walk, MD (PRINCIPAL_INVESTIGATOR)

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