Study Purpose:
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.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Primary Lateral Sclerosis (PLS) , Healthy Volunteer , Healthy Volunteer with a Family History of ALS
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
James Berry, MD (Massachusetts General Hospital) Nicholas Maragakis, MD (Johns Hopkins University)
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Massachusetts General Hospital
Sara Thrower / email hidden; JavaScript is required / 617-643-5374
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
Participant Duration:
1 year, 5 study visits
Estimated Enrollment:
1,000
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
Minimum Age:
18
Maximum Age:
100
Can participants use Riluzole?
Yes
Cedars-Sinai Medical Center
Carolyn Prina / 310-423-1713 / email hidden; JavaScript is required
Dana Fine / 310-423-8497 / email hidden; JavaScript is required
Dana Fine
Los Angeles, California
90048
United States
Emory University
Arish Jamil / 404-727-1273 / email hidden; JavaScript is required
Atlanta, Georgia
30322
United States
Northwestern University, Feinberg School of Medicine
Benjamin Joslin / 312-503-7504 / email hidden; JavaScript is required
Chicago, Illinois
60611
United States
Johns Hopkins University
Betsy Mosmiller / 410-502-0495 / email hidden; JavaScript is required
Baltimore, Maryland
21205
United States
Massachusetts General Hospital Neurological Clinical Research Institute
Mackenzie Keegan / 617-643-6252 / email hidden; JavaScript is required
Boston, Massachusetts
02114
United States
Washington University
Jesse Markway / 314-747-7881 / email hidden; JavaScript is required
Jennifer Jockel-Balsarotti / 314-362-6159 / email hidden; JavaScript is required
Jennifer Jockel-Balsarotti
St. Louis, Missouri
63110
United States
Ohio State University Medical Center
Amy Bartlett / 614-366-9050 / email hidden; JavaScript is required
Ifeanyi Okoh / 614-688-7837 / email hidden; JavaScript is required
Ifeanyi Okoh
Columbus, Ohio
43221
United States
Texas Neurology, PA
Todd Morgan / 214-279-0310 / email hidden; JavaScript is required
Dallas, Texas
75214
United States