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 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.
Study Type
OBSERVATIONAL
Enrollment
600
University of Alabama Birmingham
Birmingham, Alabama, United States
RECRUITINGBarrow Neurological Institute
Phoenix, Arizona, United States
RECRUITINGUniversity of California San Diego
La Jolla, California, United States
RECRUITINGUniversity of California Irvine
Orange, California, United States
ALS Symptoms Questionnaire
Questions to identify development of symptoms related to ALS
Time frame: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline
Environmental History
Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: at Baseline, 12, 24 and 36 months from baseline
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University of California, San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGHospital for Special Care
New Britain, Connecticut, United States
RECRUITINGGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGSaint Alphonsus Regional Medical Center
Boise, Idaho, United States
RECRUITING...and 22 more locations