Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06885918
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ALS Research Collaborative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fibroblasts, Serum, Plasma, Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2035-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALS Functional Rating Scale - Revised (ALSFRS-R)', 'timeFrame': 'Monthly, through study completion, an average of 1 year', 'description': 'A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale.'}], 'secondaryOutcomes': [{'measure': 'Machine-Learning Based Speech Scoring', 'timeFrame': 'Monthly, through study completion, an average of 1 year', 'description': 'Participants submit a scripted voice recording of 5 different, short phrases that are then scored by a machine-learning based algorithm that assess dysarthria on a non-integer scale of 0 (fully impaired) to 4 (normal speech)'}, {'measure': 'Limb-based Accelerometry', 'timeFrame': 'monthly, through study completion, an average of 6 months', 'description': 'Participants wear four, ActiGraph devices on each limb. Passive and active (video-directed) wear time data is collected over one week. The devices measure acceleration and represent the strength of each limb during movement. Outputs include activity counts and raw acceleration data.'}, {'measure': 'Medications, Supplements, and Clinical Trial Participation Surveys', 'timeFrame': 'quarterly, through study completion, an average of 1 year', 'description': 'Participants complete questionnaires describing usage information about medications and supplements they have taken and are currently taking, as well as clinical trial participation.'}, {'measure': 'Social and Environmental Surveys', 'timeFrame': 'One-time or quarterly at months 1, 4, 7, 10', 'description': 'Participants complete questionnaires about their familial, educational, and geographical background, as well as lifestyle habits and past medical conditions and injuries. These are non-current factors that may have an affect on current health outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARC', 'ALS Research Collaborative', 'ALS TDI', 'ALS Therapy Develeopment Institute'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'ALS (Amyotrophic Lateral Sclerosis)', 'ALS With Frontotemporal Dementia (ALS/FTD)', 'Motor Neuron Disease', 'Motor Neuron Disease, Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39707523', 'type': 'BACKGROUND', 'citation': 'Straczkiewicz M, Burke KM, Calcagno N, Premasiri A, Vieira FG, Onnela JP, Berry JD. Free-living monitoring of ALS progression in upper limbs using wearable accelerometers. J Neuroeng Rehabil. 2024 Dec 21;21(1):223. doi: 10.1186/s12984-024-01514-7.'}, {'pmid': '37604821', 'type': 'BACKGROUND', 'citation': 'Gupta AS, Patel S, Premasiri A, Vieira F. At-home wearables and machine learning sensitively capture disease progression in amyotrophic lateral sclerosis. Nat Commun. 2023 Aug 21;14(1):5080. doi: 10.1038/s41467-023-40917-3.'}, {'pmid': '35396385', 'type': 'BACKGROUND', 'citation': 'Vieira FG, Venugopalan S, Premasiri AS, McNally M, Jansen A, McCloskey K, Brenner MP, Perrin S. A machine-learning based objective measure for ALS disease severity. NPJ Digit Med. 2022 Apr 8;5(1):45. doi: 10.1038/s41746-022-00588-8.'}], 'seeAlsoLinks': [{'url': 'https://arc.als.net/', 'label': 'ARC Sign Up Page'}, {'url': 'https://www.als.net/arc/data-commons/', 'label': 'ARC Data Commons Inquiry Page - for researcher access to ARC data'}]}, 'descriptionModule': {'briefSummary': "The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants can be located anywhere but require internet access.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Can communicate in written English\n* Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation\n\nExclusion Criteria:\n\n* Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.'}, 'identificationModule': {'nctId': 'NCT06885918', 'acronym': 'ARC', 'briefTitle': 'ALS Research Collaborative', 'organization': {'class': 'OTHER', 'fullName': 'ALS Therapy Development Institute'}, 'officialTitle': 'ALS Translational Research Program', 'orgStudyIdInfo': {'id': 'ALSTDI0103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Person living with ALS/MND', 'description': 'An adult over the age of 18, that has received a diagnosis of ALS or other Motor Neuron Disease from a practicing physician.'}, {'label': 'Asymptomatic gene carrier', 'description': 'An adult over the age of 18 who does not have symptoms of ALS and carries a mutation known to be associated with ALS'}, {'label': 'Healthy Volunteer', 'description': 'An adult over the age of 18 who does not have any biological connection to ALS or other Motor Neuron Disease, and no significant health problems.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alan S Premasiri, M.S.', 'role': 'CONTACT', 'email': 'apremasiri@als.net', 'phone': '6174417200', 'phoneExt': '7291'}, {'name': 'Fernando G Vieira, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ALS Therapy Development Institute', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}], 'centralContacts': [{'name': 'Alan S Premasiri, M.S.', 'role': 'CONTACT', 'email': 'apremasiri@als.net', 'phone': '617-441-7200', 'phoneExt': '7291'}, {'name': 'Beth Levine', 'role': 'CONTACT', 'email': 'blevine@als.net', 'phone': '617-441-7200'}], 'overallOfficials': [{'name': 'Fernando G Vieira, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ALS Therapy Development Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALS Therapy Development Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}