Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05116943

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to collect CSF and blood samples that can be used in future research studies to identify potential biomarkers in blood and cerebrospinal fluid (CSF) collected in Amyotrophic Lateral Sclerosis (ALS) patients.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT05116943

Start date

Aug 19, 2013

Status verified date

Dec, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Blood serum collection [ Time Frame: 10 years ]
  • Blood plasma collection [ Time Frame: 10 years ]
  • Cerebrospinal fluid collection [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-16.