No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
90 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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 OR meets Gold Coast criteria
* Forced vital capacity within the last 90 days ≥ 60% …
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 OR meets Gold Coast 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 Criteria:
* 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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