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Imaging Biomarkers in ALS | Clinical Trials | Clareo Health

RECRUITING

Imaging Biomarkers in ALS

A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)

NCT02567136•University of Minnesota

Summary

The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy controls.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•21 to 75 years of age inclusive.
•Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
•ALS patients:
•A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.

Exclusion Criteria

•Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
•Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
•Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.
•The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

September 30, 2030

Completion Date

September 30, 2031

Last Updated

December 2, 2025

Enrollment

ESTIMATED participants

Conditions

Amyotrophic Lateral SclerosisPrimary Lateral Sclerosis

Contacts

Valerie Ferment

CONTACT

6123011535 ferm0016@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Imaging Biomarkers in ALS

Inclusion Criteria

Exclusion Criteria

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Control Cohort CTRL COH

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