Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
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| ClinicalTrials.gov Identifier: NCT05474235 |
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Recruitment Status :
Recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
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Sponsor:
Mayo Clinic
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Bjorn E. Oskarsson, Mayo Clinic
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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 |
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| Amyotrophic Lateral Sclerosis |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Amyotrophic lateral sclerosis
Juvenile primary lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
| Group/Cohort |
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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.
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Blood Relative of ALS Patient
Subjects with family history (first, second or third degree blood relative) of ALS or other motor neuron disease.
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Healthy Control
Subjects with no personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease
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Primary Outcome Measures :
- 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
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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
| 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
| Principal Investigator: | Bjorn Oskarsson, MD | Mayo Clinic |
Additional Information:
| 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 |
| 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 |