Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-24 @ 1:01 PM
Study NCT ID:
NCT06581861
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2024-08-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREVENT ALL ALS Study
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALS Symptoms Questionnaire', 'timeFrame': 'Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline', 'description': 'Questions to identify development of symptoms related to ALS'}], 'secondaryOutcomes': [{'measure': 'Environmental History', 'timeFrame': 'Once at Month 1 from Baseline', 'description': 'Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes'}, {'measure': 'Cognitive assessment (ECAS)', 'timeFrame': 'at Baseline, 12, 24 and 36 months from baseline', 'description': 'ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function'}, {'measure': 'Cognitive assessment (CDR-FTLD)', 'timeFrame': 'at Baseline, 12, 24 and 36 months from baseline', 'description': 'CDR-FTLD is a global assessment scale that evaluates severity of impairment across multiple domains in patients with Frontotemporal dementia (FTLD) spectrum disorders.'}, {'measure': 'Hand-Held Dynamometry (HHD)', 'timeFrame': 'at Baseline, 12, 24 and 36 months from baseline', 'description': 'HHD is used as a quantitative measure of muscle strength. This will involve testing of the bilateral deltoid, biceps, triceps, wrist extension, FDI, ADM, APB, hip extension, quadriceps, hamstring, TA and grip strength.'}, {'measure': 'Digital Speech Assessment', 'timeFrame': 'at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months', 'description': 'Participants will be asked to record voice samples at home once a month using a digital application installed on their device.'}, {'measure': 'Vital Capacity (VC)', 'timeFrame': 'at Baseline, 12, 24 and 36 months from baseline', 'description': 'It is the change in respiratory function over time as measured by Slow Vital Capacity (SVC).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALS', 'Amyotrophic Lateral Sclerosis', 'Biomarker', 'Observational', 'at-risk'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nPREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening/pre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 600 participants are planned for this study enrolled. They are aged 18 years or older, and are at risk of developing ALS.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.\n5. Access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria:\n\n1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.\n2. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\<= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures\n3. Clinically significant, unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator\'s judgment\n\nExclusion Criteria for Participants Undergoing Optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.\n\nInclusion Criteria for Genetic Testing Results Sub-study\n\n1. Age 18 years of age or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Currently enrolled in the PREVENT ALS Study'}, 'identificationModule': {'nctId': 'NCT06581861', 'briefTitle': 'PREVENT ALL ALS Study', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Hospital and Medical Center, Phoenix"}, 'officialTitle': 'PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically at Risk for Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': '2024P001131'}, 'secondaryIdInfos': [{'id': '1OT2NS136938', 'link': 'https://reporter.nih.gov/quickSearch/1OT2NS136938', 'type': 'NIH'}, {'id': '1OT2NS136939', 'link': 'https://reporter.nih.gov/quickSearch/1OT2NS136939', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melanie Benge', 'role': 'CONTACT', 'email': 'melaniebenge@uabmc.edu', 'phone': '205-975-0445'}, {'name': 'Nan Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Shiver', 'role': 'CONTACT', 'email': 'fulton.research@dignityhealth.org', 'phone': '602-406-7773'}, {'name': 'Shafeeq Ladha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gil Gutierrez', 'role': 'CONTACT', 'email': 'grg005@health.ucsd.edu', 'phone': '858-246-2325'}, {'name': 'John Ravits, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosa Gonzalez', 'role': 'CONTACT', 'email': 'rosaig1@hs.uci.edu', 'phone': '714-456-6191'}, {'name': 'Namita Goyal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah George', 'role': 'CONTACT', 'email': 'hannah.george@ucsf.edu', 'phone': '415-353-2959'}, {'name': 'Laura Rosow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexis Shepardson', 'role': 'CONTACT', 'email': 'neuroresearch@cuanschutz.edu', 'phone': '303-724-4644'}, {'name': 'Laura Foster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06053', 'city': 'New Britain', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sabine Lebel-Hardenac', 'role': 'CONTACT', 'email': 'shardenack@hfsc.org'}], 'facility': 'Hospital for Special Care', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '200007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arthur Zimmer', 'role': 'CONTACT', 'email': 'az642@georgetown.edu', 'phone': '301-956-6489'}], 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffery Gainer', 'role': 'CONTACT', 'email': 'gainer.jeffery@mayo.edu', 'phone': '(904) 953 3730'}, {'name': 'Jany Dagher', 'role': 'CONTACT', 'email': 'dagher.jany@mayo.edu'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Helena Snider', 'role': 'CONTACT', 'email': 'neuro.research@saintalphonsus.org', 'phone': '208-367-7397'}], 'facility': 'Saint Alphonsus Regional Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aeryn Hopwood', 'role': 'CONTACT', 'email': 'aeryn.hopwood@northwestern.edu', 'phone': '312-503-5166'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Micheels', 'role': 'CONTACT', 'email': 'amicheel@iu.edu', 'phone': '317-963-7385'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Delayna Willie', 'role': 'CONTACT', 'email': 'dwillie2@jh.edu', 'phone': '(410)502-6597'}], 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katelyn Porter', 'role': 'CONTACT', 'email': 'katelyn.porter@nih.gov', 'phone': '301-451-1229'}], 'facility': 'Nih/Ninds', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02145', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Courtney Uek', 'role': 'CONTACT', 'email': 'mghpreventallals@mgb.org', 'phone': '(617) 724-0783'}], 'facility': 'Massachusetts General Brigham', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caroline Piecuch', 'role': 'CONTACT', 'email': 'carolinp@med.umich.edu', 'phone': '734-936-8781'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Vallie', 'role': 'CONTACT', 'email': 'avallis1@hfhs.org', 'phone': '313-916-1364'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Munoz', 'role': 'CONTACT', 'email': 'munoz156@umn.edu', 'phone': '612-624-9989'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesse Markway', 'role': 'CONTACT', 'email': 'als@wustl.edu', 'phone': '844-257-2273'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathan McKain', 'role': 'CONTACT', 'email': 'nmckain@unmc.edu', 'phone': '(402) 552-6241'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Sullivan', 'role': 'CONTACT', 'email': 'neuroresearch@hitchcock.org', 'phone': '603-650-6496'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ben Hoover', 'role': 'CONTACT', 'email': 'bnh2119@cumc.columbia.edu', 'phone': '646-574-7399'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'alsresearch@dm.duke.edu'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carly Failor', 'role': 'CONTACT', 'email': 'alsresearch@osumc.edu', 'phone': '614-293-4973'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberly Perry', 'role': 'CONTACT', 'email': 'kimberly.perry2@providence.org', 'phone': '(971) 231-8245'}], 'facility': 'Providence ALS Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele Hare', 'role': 'CONTACT', 'email': 'nervemuscle@pennstatehealth.psu.edu', 'phone': '717-531-8257'}], 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Furey', 'role': 'CONTACT', 'email': 'tuf40109@temple.edu', 'phone': '267-694-0573'}], 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75206', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haley Rucker', 'role': 'CONTACT', 'email': 'hrucker@texasneurology.com', 'phone': '214-827-3610'}], 'facility': 'Texas Neurology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Redlin', 'role': 'CONTACT', 'email': 'scott.redlin@utah.edu', 'phone': '801-581-7437'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brianna Schibley-Laird', 'role': 'CONTACT', 'email': 'brianna.schibleylaird@vcuhealth.org', 'phone': '315-651-9378'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lila Brisk', 'role': 'CONTACT', 'email': 'lbrisk@uw.edu', 'phone': '206-543-0454'}, {'name': 'Kinsey Chapman', 'role': 'CONTACT', 'email': 'kinseyc@uw.edu', 'phone': '(206) 543-0081'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00935', 'city': 'San Juan', 'state': 'Puerto Rico', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Frances M Aponte', 'role': 'CONTACT', 'email': 'frances.aponte2@upr.edu', 'phone': '787-767-9194'}], 'facility': 'CHALS-CCT, University of Puerto Rico, Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'ALL ALS Patient Navigator', 'role': 'CONTACT', 'email': 'info@all-als.org', 'phone': '602-845-0248'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Hospital and Medical Center, Phoenix", 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Foundation for the National Institutes of Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}