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, Primary Lateral Sclerosis (PLS), Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Enrolling

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

Massachusetts 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) 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:

05/01/2018

Date Study Added to alsconsortium.org:

11/11/2015
  • More Information

    Want to learn more about Answer ALS? Click here to watch a recording of the May 5, 2016 webinar, which provides an overview of the short and long term goals of the initiative.

  • 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

    Cedars-Sinai Medical Center
    Carolyn Prina / .(JavaScript must be enabled to view this email address) / 310-423-1713
    Dana Fine / .(JavaScript must be enabled to view this email address) / 310-423-8497
    127 S. San Vicente Blvd.
    Los Angeles, California 90048
    United States

    Emory University
    Arish Jamil / .(JavaScript must be enabled to view this email address) / 404-727-1273
    The Emory ALS Center
    Atlanta, Georgia 30322
    United States

    Northwestern University, Feinberg School of Medicine
    Benjamin Joslin / .(JavaScript must be enabled to view this email address) / 312-503-7504
    / 710 N. Lake Shore Dr.
    Chicago , Illinois 60611
    United States

    Johns Hopkins University
    Betsy Mosmiller / .(JavaScript must be enabled to view this email address) / 410-502-0495
    Department of Neurology
    Baltimore, Maryland 21205
    United States

    Massachusetts General Hospital Neurological Clinical Research Institute
    Brixhilda Dedi / .(JavaScript must be enabled to view this email address) / 617-726-4284
    Jacqueline Andrews / .(JavaScript must be enabled to view this email address) / 617-726-0981
    165 Cambridge St.
    Boston, Massachusetts 02114
    United States

    Washington University
    Jesse Markway / .(JavaScript must be enabled to view this email address) / 314-747-7881
    Jennifer Jockel-Balsarotti / .(JavaScript must be enabled to view this email address) / 314-362-6159
    Department of Neurology
    St. Louis, Missouri 63110
    United States

    Ohio State University Medical Center
    Amy Bartlett / .(JavaScript must be enabled to view this email address) / 614-366-9050
    Ifeanyi Okoh / .(JavaScript must be enabled to view this email address) / 614-688-7837
    Neuromuscular Division
    Columbus, Ohio 43221
    United States

    Texas Neurology, PA
    Todd Morgan / .(JavaScript must be enabled to view this email address) / 214-279-0310
    6301 Gaston Avenue
    Dallas, Texas 75214
    United States