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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116943
• Other study ID #: 13-004314
• Secondary ID: 5P01NS084974-07
• Status: Recruiting
• Start date: August 19, 2013
• Est. completion date: January 2030

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neurodegenerative Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood serum collection	Total number of blood serum samples collected	10 years
Primary	Blood plasma collection	Total number of blood plasma samples collected	10 years
Primary	Cerebrospinal fluid collection	Total number of cerebrospinal fluid samples collected	10 years

External Links

•   Mayo Clinic Clinical Trials