A Longitudinal Analysis of Biomarkers in Patients with ALS

Study Purpose:

The purpose of this study is to longitudinally collect blood, urine, and CSF (optional) from ALS patients/healthy volunteers to look for potential new biomarkers. Biomarkers will be tested over time in anticipation of identifying new biomarkers, which may help us to diagnose and monitor people with ALS, and to learn about potential causes and treatments for ALS.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Healthy Volunteer , Asymptomatic ALS gene carriers

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

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

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

Clinicaltrials.gov ID:

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital

Lisa Ramdas / email hidden; JavaScript is required / (617) 724-9196

165 Cambridge Street

Full Study Summary:

A biomarker is a molecule found in the body that we can measure and use to monitor a disease state. Biomarkers are found in blood, urine, and cerebrospinal fluid, as well as other soft tissues. We would like to see how levels of different biomarkers change over time in people with Amyotrophic Lateral Sclerosis (ALS). Several potential biomarkers for ALS have been identified in blood from small groups of people with ALS. Through this study, we hope to test these potential biomarkers over time, look for new ones which may help diagnose and monitor people with ALS, and learn about potential causes and treatments for ALS. We are collecting samples from subjects with ALS, asymptomatic ALS gene carriers, and healthy volunteers without a neurological disease to be used for comparison. An asymptomatic ALS gene carrier is someone who has an ALS causing gene, but no apparent symptoms of ALS. Other outcome measures include demographics and medical history completion, ALSFRS-R questionnaire, and Slow Vital Capacity test.

Study Sponsor:

Participant Duration:

Visits occur every 3 months for a maximum of 7 visits. Visits are typically 1-2 hours.

Estimated Enrollment:

150 healthy volunteers and 150 ALS volunteers

Estimated Study Start Date:

06 / 25 / 2021

Posting Last Modified Date:

10 / 08 / 2021

Date Study Added to neals.org:

10 / 08 / 2021

Accepts healthy volunteers:

Yes

Minimum Age:

18

Can participants use Riluzole?

Yes

Participants must be 18 years of age or older; must be capable of providing consent; and must be capable of complying with study procedures. ALS participants must be diagnosed with familial or sporadic ALS according to the EL Escorial Criteria. Participants cannot have other neurodegenerative diseases; and cannot have a history of unstable mental illness.

Neurological Clinical Research Institute and the Sean M. Healey & AMG Center for ALS, Massachusetts General Hospital

Lisa Ramdas / (617) 724-9196 / email hidden; JavaScript is required

Boston, Massachusetts 02114
United States