Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-28 @ 4:07 PM
Study NCT ID:
NCT05474235
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2022-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Collection', 'timeFrame': '50 years', 'description': 'Total number of blood samples collected'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nALS or Suspected ALS Patient\n\n* 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\n* Blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features; OR:\n\n * A clinical suspicion or referral for ALS;\n * \\> 18 years of age;\n * Willing and able to give signed informed consent or assent that has been approved by the Institutional Review Board (IRB).\n\nBlood Relative of ALS Patient\n\n* Family history (first, second or third degree blood relative) of ALS or other motor neuron disease;\n* \\> 18 years of age;\n* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).\n\nHealthy Control\n\n* No personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease;\n* \\> 18 years of age;\n* No personal history of other neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease);\n* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).\n\nExclusion Criteria:\n\nALS or Suspected Patient • Limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures.\n\nBlood Relative of ALS Patient\n\n• Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.\n\nHealthy Control Subject\n\n* Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.);\n* Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.'}, 'identificationModule': {'nctId': 'NCT05474235', 'briefTitle': 'Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders', 'orgStudyIdInfo': {'id': '07-005711'}, 'secondaryIdInfos': [{'id': '5P01NS084974', 'link': 'https://reporter.nih.gov/quickSearch/5P01NS084974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALS or Suspected ALS Patient', 'description': '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.'}, {'label': 'Blood Relative of ALS Patient', 'description': 'Subjects with family history (first, second or third degree blood relative) of ALS or other motor neuron disease.'}, {'label': 'Healthy Control', 'description': 'Subjects with no personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chris Liriano', 'role': 'CONTACT', 'email': 'liriano.christion@mayo.edu', 'phone': '904-953-5325'}], 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Bjorn Oskarsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bjorn E. Oskarsson', 'investigatorAffiliation': 'Mayo Clinic'}}}}