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.
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Primary Lateral Sclerosis (PLS) , Healthy Volunteer , Healthy Volunteer with a Family History of ALS
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
James Berry, MD (Massachusetts General Hospital) Nicholas Maragakis, MD (Johns Hopkins University)
Coordinating Center Contact Information
Massachusetts 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.
Robert Packard Center for ALS Research and ALS Finding a Cure
1 year, 5 study visits
Estimated Study Start Date:
12 / 01 / 2015
Estimated Study Completion Date:
07 / 31 / 2019
Posting Last Modified Date:
12 / 14 / 2020
Date Study Added to neals.org:
11 / 11 / 2015
Can participants use Riluzole?
Cedars-Sinai Medical Center
Los Angeles, California
Northwestern University, Feinberg School of Medicine
Johns Hopkins University
Massachusetts General Hospital Neurological Clinical Research Institute
St. Louis, Missouri
Ohio State University Medical Center
Texas Neurology, PA