ASSESS ALL ALS Study
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT06578195
- Lead Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Brief 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 being 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALS Functional Rating Scale-Revised (ALSFRS-R) Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only. 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.
ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE) Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only 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.
- Secondary Outcome Measures
Name Time Method Environmental History Month 1 for all cohorts Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc.
ALS Impairment Multidomain scale (AIMS) 1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only Questionnaires completed by participants that assess severity of the ALS disease
Social Determinants of Health Months 3 and 4 for all cohorts Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Cognitive assessment (ECAS) Baseline, 12 and 24 months for all cohorts ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function
Vital Capacity Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Digital Speech Assessment Baseline, and monthly (at month 1,2, 3 through month 24 from baseline) Participants will be asked to record voice samples at home once a month using a digital application installed on their device.
HHD of 3 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 Hand-held dynamometry (HHD) will be used as a quantitative measure of muscle strength for the three intrinsic hand muscles, bilaterally
Trial Locations
- Locations (32)
University of California San Diego
🇺🇸La Jolla, California, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Nih/Ninds
🇺🇸Bethseda, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Providence ALS Center
🇺🇸Portland, Oregon, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Hospital For Special Care
🇺🇸New Britain, Connecticut, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
John Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Brigham
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Ohio State University
🇺🇸Colombus, Ohio, United States
Penn State Health
🇺🇸Hershey, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Texas Neurology
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
🇵🇷San Juan, Puerto Rico