Analysis of Immune Activation in the Peripheral Blood of Patients with ALS

Study Purpose:

The purpose of this study is to learn more about the role of the immune system in ALS and find unique biological markers, which could be used to develop new therapies.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Not enrolling

Phase:

Not Applicable

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

James D. Berry, MD, MPH (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
MaryAngel Jeon / .(JavaScript must be enabled to view this email address) / 617-724-9196
.(JavaScript must be enabled to view this email address) Neurological Clinical Research Institute (NCRI)
165 Cambridge Street, Suite 600
Boston, Massachusetts 02114 United States

Full Study Summary:

The purpose of the research study is to collect blood samples from people with amyotrophic lateral sclerosis (ALS) and control volunteers. Through comparison of these samples, the researchers hope to learn more about the role of the immune system in ALS, as well as find unique biological markers, which could be used to develop new therapies.

Study Sponsor:

Departmental funds

Participant Duration:

Control subjects will participate in a one-time blood draw and ALS subjects will participate in up to 7 brief sample collection visits every 3 months. Each visit will require up to 1 hour of the subject™s time. All visits will take place at the main campus of Massachusetts General Hospital.

Estimated Enrollment:

100 ALS, 100 Healthy Controls

Estimated Study Start Date:

11/30/2012

Estimated Study Completion Date:

11/02/2016

Posting Last Modified Date:

01/11/2018

Date Study Added to alsconsortium.org:

12/06/2012

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
18
Maximum Age:
N/A

Time since Symptom Onset:

Time since Diagnosis:

Can participants use Riluzole?

Inclusion Criteria:
ALS Subjects only:
ALS subjects diagnosed with familial or sporadic ALS as according to the El Escorial Criteria (possible, probable — lab supported, probable, or definite) or individuals with known gene mutations associated with ALS (regardless of clinical phenotype)

Control Subjects only: Absence of autoimmune myopathy, neuropathy, ALS mimic disorder, or any other neurodegenerative disease or known diagnosis of ALS

Exclusion Criteria:
Use of any immunomodulatory medication (including Prednisone), currently or within 30 days of screening
Known autoimmune disease
Clinically significant history of unstable medical illness
Site Contact Information

Massachusetts General Hospital
MaryAngel Jeon / .(JavaScript must be enabled to view this email address) / 617-724-9196
Neurological Clinical Research Institute
Boston, Massachusetts 02114
United States