We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05116943
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : November 10, 2022
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Bjorn E. Oskarsson, Mayo Clinic

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.

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Biospecimen Biorepository for the Study of ALS, ALS-FTD and Similar Neurodegenerative Disorders
Actual Study Start Date : August 19, 2013
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030





Primary Outcome Measures :
  1. Blood serum collection [ Time Frame: 10 years ]
    Total number of blood serum samples collected

  2. Blood plasma collection [ Time Frame: 10 years ]
    Total number of blood plasma samples collected

  3. Cerebrospinal fluid collection [ Time Frame: 10 years ]
    Total number of cerebrospinal fluid samples collected



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116943


Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Alex Burch, BA    904-953-2000    burch.alex@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Bjorn Oskarsson, MD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Bjorn E. Oskarsson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05116943    
Other Study ID Numbers: 13-004314
5P01NS084974-07 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases