Answer ALS: Individualized Initiative for ALS Discovery

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

James Berry, MD (Massachusetts General Hospital)
Nicholas Maragakis, MD (Johns Hopkins University)

Clinicaltrials.gov ID (11 digit #):

NCT02574390

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital
Sara Thrower / .(JavaScript must be enabled to view this email address) / (617) 643-5374
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
6th Floor
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:

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    100

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


  • Site Contact Information

    Ohio State University Medical Center
    Sharon Chelnick / .(JavaScript must be enabled to view this email address) / 614-293-4973
    Neuromuscular Division
    Columbus, Ohio 43221
    United States

    Cedars-Sinai Medical Center
    Ashley Fetterman / .(JavaScript must be enabled to view this email address) / 310-423-8497
    127 S. San Vicente Blvd.
    Los Angeles, California 90048
    United States

    Washington University
    Molly McCallum / .(JavaScript must be enabled to view this email address) / 314-362-6159
    Department of Neurology
    St. Louis, Missouri 63110
    United States

    Emory University
    Arish Jamil / .(JavaScript must be enabled to view this email address) / 404-712-1273
    The Emory ALS Center
    Atlanta, Georgia 30322
    United States

    Johns Hopkins University
    Aiana Rodriguez / .(JavaScript must be enabled to view this email address) / 410-287-0627
    Department of Neurology
    Baltimore, Maryland 21205
    United States

    Massachusetts General Hospital Neurological Clinical Research Institute
    Leah Miller / .(JavaScript must be enabled to view this email address) / 617-724-7398
    165 Cambridge St.
    Boston, Massachusetts 02114
    United States