Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS

Study Purpose:

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized by progressive muscle weakness and eventual death. Studies demonstrate that the immune system plays a key role in ALS progression; however, the role of the immune system is unclear, as various aspects can play both a beneficial and detrimental role in the disease course. Attempts to universally suppress the immune system in ALS patients have at best had negligible effects on progression or at worst accelerated the disease. Thus, there is a critical need to identify immune cell populations to serve as biomarkers and therapeutic targets.

Disease:

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

Study Type:

Observational Study

Study Category:

Blood draw

Study Status:

Enrolling

Phase:

Not Applicable

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

Ben Murdock, PhD, University of Michigan

Clinicaltrials.gov ID (11 digit #):

NCT03090932

Neals Affiliated?

Coordinating Center Contact Information

University of Michigan
Blake Swihart / .(JavaScript must be enabled to view this email address) / 734-763-8284
.(JavaScript must be enabled to view this email address) Ann Arbor, Michigan 48109 United States

Full Study Summary:

Study Sponsor:

University of Michigan

Participant Duration:

Estimated Enrollment:

250

Estimated Study Start Date:

01/18/2016

Estimated Study Completion Date:

12/31/2021

Posting Last Modified Date:

01/27/2020

Date Study Added to alsconsortium.org:

05/02/2017

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
18
Maximum Age:
80

Time since Symptom Onset:
N/A
Time since Diagnosis:
N/A
Can participants use Riluzole?
Yes

Inclusion Criteria:

Age 18 years or older.
Fluency in English at the 6th grade level or higher.
Able to communicate sufficiently well by speaking
Able to communicate over the phone.
Capable of providing informed consent.
Lives within 1 hour of the University of Michigan

Exclusion Criteria:

Definite, probable, or possible ALS diagnosis
Unable to provide informed consent.
Clinically significant dementia, as judged by the site investigator.
Other neurological or psychiatric disorders which are expected to impair cognitive function.
Other serious and uncontrolled medical disorders.
History of autoimmune disease.
Use of prednisone, IVIG, or immunosuppression within the last 12 months.
Lives more than 1 hour from the University of Michigan
Site Contact Information

University of Michigan
Blake Swihart / 734-763-8284
Ann Arbor, Michigan 48109
United States