PREVENT ALL ALS Study
NCT Number: NCT06581861
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2029-07-25

Summary:
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.

PREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for upto 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.

Primary Outcome Measures: ALS Symptoms Questionnaire, Questions to identify development of symptoms related to ALS, Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline
Secondary Outcome Measures: Environmental History, Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes, Once at Month 1 from Baseline|Cognitive assessment (ECAS), ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function, at Baseline, 12, 24 and 36 months from baseline|Cognitive assessment (CDR-FTLD), CDR-FTLD is a global assessment scale that evaluates severity of impairment across multiple domains in patients with Frontotemporal dementia (FTLD) spectrum disorders., at Baseline, 12, 24 and 36 months from baseline|Hand-Held Dynamometry (HHD), 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., at Baseline, 12, 24 and 36 months from baseline|Digital Speech Assessment, Participants will be asked to record voice samples at home once a month using a digital application installed on their device., at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months|Vital Capacity (VC), It is the change in respiratory function over time as measured by Slow Vital Capacity (SVC)., at Baseline, 12, 24 and 36 months from baseline