Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581861
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
PREVENT ALL ALS Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically At Risk for Amyotrophic Lateral Sclerosis ALS
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 begin funded by the National Institutes of HealthNational Institute of Neurological Disorders and Stroke NIHNINDS 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-siteremote 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 samplesThe 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 screeningpre-test genetic counseling visit a return of genetic results and a post-test counseling visit
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-siteremote 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 samplesThe 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 screeningpre-test genetic counseling visit a return of genetic results and a post-test counseling visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None