A Multicenter Study for the Discovery and Validation of ALS Biomarkers

Study Purpose:

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research.

Disease:

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

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Completed

Phase:

Not Applicable

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

Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
James D. Berry, MD, MPH (Massachusetts General Hospital)
Robert Bowser, PhD (Barrow Neurological Institute)
Robert Brown, MD, D. Phil (UMASS)
Kevin Boylan, MD (Mayo Clinic Jacksonville)
Jonathan Glass, MD (Emory University)
David Lacomis, MD (University of Pittsburgh)

Clinicaltrials.gov ID (11 digit #):

NCT01495390

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital
Daniela Grasso / .(JavaScript must be enabled to view this email address) / 617-726-0842
.(JavaScript must be enabled to view this email address) Neurological Clinical Research Institute (NCRI)
165 Cambridge Street, 6th Floor
Boston, Massachusetts 02114 United States

Full Study Summary:

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months. Through comparison of these specimens, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

Study Sponsor:

ALS Therapy Alliance

Participant Duration:

up to 36 months

Estimated Enrollment:

up to 250

Estimated Study Start Date:

07/31/2011

Estimated Study Completion Date:

12/31/2016

Posting Last Modified Date:

01/19/2017

Date Study Added to alsconsortium.org:

12/20/2011
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    Age 18 or older
    Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
    Vital capacity (VC) at least 50 percent predicted
    Able to undergo multiple lumbar punctures

    Exclusion Criteria:
    Abnormal CSF pressure or intracranial/intraspinal tumors
    Use of anticoagulant medication that cannot be safely withheld
    Bleeding disorders

    This is a partial listing.

  • Site Contact Information

    Barrow Neurological Institute
    Gale Kittle / .(JavaScript must be enabled to view this email address) / 602-406-4792
    500 West Thomas Road
    Phoenix, Arizona 85013
    United States

    University of Pittsburgh
    Danielle Rowlands, RN / .(JavaScript must be enabled to view this email address) / 412-648-9053
    200 Lothrop St
    Pittsburgh, Pennsylvania 15213
    United States

    UMASS Medical Center
    Diane McKenna-Yasek / .(JavaScript must be enabled to view this email address) / 508-856-4697
    55 Lake Ave North
    Worcester, Massachusetts 01655
    United States

    Mayo Clinic Jacksonville
    Amelia Robertson / .(JavaScript must be enabled to view this email address) / 904-953-9498
    4500 San Pablo Rd
    Jacksonville, Florida 32224
    United States

    Emory University
    Meraida Polak / .(JavaScript must be enabled to view this email address) / 404-778-3807
    101 Woodruff Circle, Suite 6000
    Atlanta, Georgia 30322
    United States

    Massachusetts General Hospital
    Leah Miller / .(JavaScript must be enabled to view this email address) / 617-724-7398
    Boston, Massachusetts 02114
    United States