Biospecimen Biorepository for the Study of ALS, ALS-FTD and Similar Neurodegenerative Disorders

NCT05116943 | Recruiting

• 2 other identifiers: 13-0043145P01NS084974-07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Blood serum collection

  Total number of blood serum samples collected

  10 years

• Blood plasma collection

  Total number of blood plasma samples collected

  10 years

• Cerebrospinal fluid collection

  Total number of cerebrospinal fluid samples collected

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with ALS and similar neurodegenerative disorders and their family members will be identified from patients seen in the Department of Neurology at Mayo Clinic Florida on the basis of a diagnosis of ALS or a similar neurodegenerative disorder.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bjorn Oskarsson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: August 19, 2013
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)