Health Trials

Multicenter ALS Imaging Study

ConditionsAmyotrophic Lateral SclerosisALS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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 criteria

Qualifiers

< 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

Disqualifiers

Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.

All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.

Trial design

Treatments tested in this trial

  • Magnetic Resonance Imaging
  • Plasma neurofilament light chain (NfL) quantification

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

3
University of Florida32608, GainesvilleFlorida, United States
Northwestern University60208, EvanstonIllinois, United States
University of Minnesota55455, MinneapolisMinnesota, United States

Sponsors and collaborators

University of Minnesota

Lead sponsor

Food and Drug Administration (FDA)

Collaborator

Minnesota Office of Higher Education

Collaborator

Source ClinicalTrials.gov