RecruitingNCT06735014

Multicenter ALS Imaging Study

Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development


Sponsor

University of Minnesota

Enrollment

90 participants

Start Date

Sep 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria2

  • 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.

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Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

Participants will undergo 3T MRI scanning of the brain and cervical spine MRIs

DIAGNOSTIC_TESTPlasma neurofilament light chain (NfL) quantification

Participants will undergo a blood draw for the quantification of plasma neurofilament light chain


Locations(3)

University of Florida

Gainesville, Florida, United States

Northwestern University

Evanston, Illinois, United States

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06735014


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