Collecting blood and CSF samples to study ALS and related disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather cerebrospinal fluid (CSF) and blood samples from patients diagnosed with Amyotrophic Lateral Sclerosis (ALS), ALS-Frontotemporal Dementia (ALS-FTD), and similar neurodegenerative disorders. The collected samples will be used in future research to identify potential biomarkers that could aid in the diagnosis and monitoring of ALS. By analyzing these biomarkers over time, researchers hope to understand how they change and their relevance in managing the disease. The study also includes family members of affected individuals to broaden the understanding of ALS-related biomarkers.

Why it matters

Who can join: the full rules

Inclusion Criteria - Patient with ALS, ALS-FTD or Similar Neurodegenerative Disease:

* Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified eL Escorial criteria, suspected ALS according to original el Escorial criteria, or diagnosis of a similar neurodegenerative disorder.
* Willing to provide consent, or assent, if physically unable to consent owing to disease-related muscle weakness.

Inclusion Criteria - Spouse/Domestic Partner of Patients with ALS/ALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:

* No personal history of ALS, ALS-FTD or other motor neuron disease.
* Subjects with family history of ALS, ALS-FTD the affected family member needs to be a first, second, or third degree blood relative.
* Willing to provide consent.

Exclusion Criteria - Subject with ALS/ALS-FTD or Similar Neurodegenerative Disease:

* History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be caused by another unrelated disorder.
* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.
* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.

Exclusion Criteria - Spouse/Domestic Partner of Patients with ALS/ALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:

* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.
* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.

Where it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Bjorn Oskarsson, MD — Mayo Clinic

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.