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

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging , 

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Bjorn Oskarsson, MD Mayo Clinic

Clinicaltrials.gov ID (11 digit #):

NCT05116943

Neals Affiliated?

No

Coordinating Center Contact Information

Mayo Clinic in Florida
Alex Burch, BA / .(JavaScript must be enabled to view this email address) / 904-953-2000
.(JavaScript must be enabled to view this email address) Jacksonville, Florida 32224 United States

Full Study Summary:

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.

Study Sponsor:

Mayo Clinic

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

08/19/2013

Estimated Study Completion Date:

01/01/2030

Posting Last Modified Date:

01/07/2022

Date Study Added to alsconsortium.org:

01/07/2022
  • Eligibility Criteria

    Gender:

    Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes



    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.
    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.

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