Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis (TRACK-ALS)
Study Purpose:
The goal is to identify imaging biomarkers in people with ALS to expand the understating of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Healthy VolunteerStudy Type:
Observational StudyStudy Category:
Biomarkers/ImagingStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Nazem Atassi, MD, MMSc —Principal Investigator (Massachusetts General Hospital)
Joseph Masdeu, MD, PhD —Co-Principal Investigator (Methodist Neurological Institute)
Stanley Annel, MD —Co-Principal Investigator (Methodist Neurological Institute)
Clive Svendsen, PhD —Co-Principal Investigator (Cedars-Sinai Medical Center)
Clinicaltrials.gov ID (11 digit #):
NCT02559869Neals Affiliated?
YesCoordinating Center Contact Information
Massachusetts General Hospital NCRIMelissa Ricker / .(JavaScript must be enabled to view this email address) / 617-643-3222
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Boston, Massachusetts 02114 United States
Full Study Summary:
This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.
In this trial, approximately 200 subjects will be screened and 100 enrolled in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and gender matched to 50 participants with no known neurological disorder (healthy controls). Of these, twenty five (25) ALS participants will be age, (±5 years) gender and binding affinity (TSPO) matched to 25 healthy controls.
Study Sponsor:
ALS finding a cure (ALSA), ALS AssociationParticipant Duration:
18 Months with follow-up every 3 months thereafter