RecruitingRecruiting
Biospecimen Biorepository for the Study of ALS, ALS-FTD and Similar Neurodegenerative Disorders
NCT05116943 · Mayo Clinic
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Biomarkers are non-genetic elements in your blood and CSF that may help diagnose and monitor ALS more easily. There are no readily available sources of longitudinal CSF, plasma or serum samples from people with ALS, ALS-FTD or similar neurodegenerative disorders or their family members for use in the identification of potential ALS biomarkers. Future research will examine potential biomarkers in blood and CSF collected over time to see if they change over time and can be used to diagnose and monitor people with ALS.
Eligibility criteria
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.
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2013-08-19
Estimated completion: 2030-01
Last updated: 2025-12-16
Primary outcomes
- • Blood serum collection (10 years)
- • Blood plasma collection (10 years)
- • Cerebrospinal fluid collection (10 years)
Sponsor
Mayo Clinic · other
With: National Institute of Neurological Disorders and Stroke (NINDS)
Contacts & investigators
InvestigatorBjorn Oskarsson, MD · principal_investigator, Mayo Clinic
All locations (1)
Mayo Clinic in FloridaRecruiting
Jacksonville, Florida, United States