Answer ALS: Individualized Initiative for ALS Discovery
The purpose of this study is to create a large repository of induced pluripotent stem cells (iPSC), bio-fluid samples (blood and spinal fluid (optional), and cell lines for ALS gene identification.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Observational Study
Study Status:Active, currently recruiting
Study Chair(s)/Principal Investigator(s):
James Berry, MD (Massachusetts General Hospital)
Nicholas Maragakis, MD (Johns Hopkins University)
Clinicaltrials.gov ID (11 digit #):NCT02574390
Coordinating Center Contact InformationMass General Hospital
Boston, Massachusetts 02114 United States
Full Study Summary:
This research is being done to create a large repository of cells called induced pluripotent stem cells (iPSC), bio-fluid samples (blood and spinal fluid (optional)), and cell lines for ALS gene identification. This will be combined carefully with collected measures of the pattern of the symptoms people with ALS have and how these change over time.
This study will be conducted at approximately 6 Northeast ALS Consortium Centers (NEALS) in the United States. A total of 1,000 participants will be enrolled. Enrollment is anticipated to occur over approximately 3 years. Research participants with early ALS and suspected ALS will be seen at the Screening/Visit 1 and follow-up will occur at 3-month intervals for 12 months. The purpose of study visits is to confirm the accuracy of initial diagnosis, evaluate disease status and progression, and to collect longitudinal samples from research participants with ALS. Clinical measures, outcome measures, and bio-fluid collection will happen at each visit.
Study Sponsor:Robert Packard Center for ALS Research and ALS Finding a Cure
1 year, 5 study visits
Estimated Study Start Date:11/30/2015
Estimated Study Completion Date:11/30/2018
Posting Last Modified Date:09/18/2017
Date Study Added to alsconsortium.org:11/11/2015
Time since Symptom Onset:N/A
Time since Diagnosis:N/A
Can participants use Riluzole?Yes
Site Contact Information
Ohio State University Medical Center
Columbus, Ohio 43221
Cedars-Sinai Medical Center
127 S. San Vicente Blvd.
Los Angeles, California 90048
Department of Neurology
St. Louis, Missouri 63110
The Emory ALS Center
Atlanta, Georgia 30322
Johns Hopkins University
Department of Neurology
Baltimore, Maryland 21205
Massachusetts General Hospital Neurological Clinical Research Institute
165 Cambridge St.
Boston, Massachusetts 02114