ASSESS ALL ALS Study
NCT Number: NCT06578195
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Collaborators: Massachusetts General Hospital|National Institute of Neurological Disorders and Stroke (NINDS)|Foundation for the National Institutes of Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2029-07-25
Locations: Barrow Neurological Institute, Phoenix, Arizona, 85013, United States|Massachusetts General Brigham, Boston, Massachusetts, 02145, United States|Washington University, Saint Louis, Missouri, 63110, United States

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.

ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include 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 a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.

Primary Outcome Measures: ALS Functional Rating Scale-Revised (ALSFRS-R), Questionnaire administered by a clinician that includes a series of questions about participants' ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function., Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.|ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE), Questionnaires completed by participants that includes questions about participants ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function., Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only
Secondary Outcome Measures: ALS Impairment Multidomain scale (AIMS), Questionnaires completed by participants that assess severity of the ALS disease, 1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only|Social Determinants of Health, Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes, Months 3 and 4 for all cohorts|Environmental History, Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc., Month 1 for all cohorts|Cognitive assessment (ECAS), ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function, Baseline, 12 and 24 months for all cohorts|Vital Capacity, Change in respiratory function over time as measured by Slow Vital Capacity (SVC)., Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants|Digital Speech Assessment, Participants will be asked to record voice samples at home once a month using a digital application installed on their device., Baseline, and monthly (at month 1,2, 3 through month 24 from baseline)|HHD of 3 hand muscles bilaterally, Hand-held dynamometry (HHD) will be used as a quantitative measure of muscle strength for the three intrinsic hand muscles, bilaterally, Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants