Observational {{label}}

Imaging Biomarkers in ALS

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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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.

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
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Join the ALS Research Collaborative (ARC) Study Today!
Ready to make a difference in ALS research?
Join the ARC Study! Whether you're living with ALS or an asymptomatic gene carrier, your participation can help inform ALS research and lead to new treatments.
ALS Research Collaborative
Thank You to Our Sponsors
Mitsubishi Tanabe Pharma