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Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron 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: NCT05474235
Recruitment Status : Recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 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, from patients with sporadic and familial ALS and their family members, clinical data and blood samples for extraction of DNA, RNA, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to ALS pathogenesis. Blood samples for DNA extraction also would be collected from control subjects with no personal or family history of ALS phenotypes.

Condition or disease
Amyotrophic Lateral Sclerosis

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders
Actual Study Start Date : December 2007
Estimated Primary Completion Date : December 2038
Estimated Study Completion Date : December 2038


Group/Cohort
ALS or Suspected ALS Patient
Subjects with clinical diagnosis of possible, laboratory-supported probable, probable or definite, ALS or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features or a blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features.
Blood Relative of ALS Patient
Subjects with family history (first, second or third degree blood relative) of ALS or other motor neuron disease.
Healthy Control
Subjects with no personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease



Primary Outcome Measures :
  1. Blood Collection [ Time Frame: 50 years ]
    Total number of blood samples collected



Information from the National Library of Medicine

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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
Eligible subjects with ALS or suspected ALS or family history of ALS will be identified from patients seen in the Department of Neurology at Mayo Clinic Jacksonville. Inclusion criteria include standardized diagnostic criteria for ALS as used in ALS therapeutic trials and patients with clinically suspected ALS.
Criteria

Inclusion Criteria

ALS or Suspected ALS Patient

  • 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 neurodegenerative disorder with evidence of ALS plus extramotor features; OR
  • Blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features; OR:

    • A clinical suspicion or referral for ALS;
    • > 18 years of age;
    • Willing and able to give signed informed consent or assent that has been approved by the Institutional Review Board (IRB).

Blood Relative of ALS Patient

  • Family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
  • > 18 years of age;
  • Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Healthy Control

  • No personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
  • > 18 years of age;
  • No personal history of other neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease);
  • Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Exclusion Criteria:

ALS or Suspected Patient • Limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures.

Blood Relative of ALS Patient

• Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.

Healthy Control Subject

  • Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.);
  • MoCA score < 26;
  • Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.

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): NCT05474235


Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Alex Burch    904-953-4724    burch.alexander@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Bjorn Oskarsson, MD Mayo Clinic
Additional Information:
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Responsible Party: Bjorn E. Oskarsson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05474235    
Other Study ID Numbers: 07-005711
5P01NS084974 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2022    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022

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