Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05137665

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Led by Target ALS Foundation, Inc. · Updated on 2025-11-21

1000

Participants Needed

12

Research Sites

552 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.

CONDITIONS

Official Title

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • For ALS participants: diagnosis of ALS by Gold Coast criteria
  • For ALS participants: Full Vital Capacity of 30% or higher or approved by Principal Investigator
  • Ability to provide informed consent and understand study risks and purpose
  • Ability to comply with study procedures as judged by Principal Investigator
  • For healthy controls: no history of neurological disease
  • For healthy controls: no known ALS-associated genetic mutations at consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 12 locations

1

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

2

University of California San Diego

San Diego, California, United States, 92121

Actively Recruiting

3

Georgetown University

Georgetown, District of Columbia, United States, 20007

Actively Recruiting

4

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

6

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

7

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

8

Columbia University

New York, New York, United States, 10032

Actively Recruiting

9

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

10

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

11

Instituto Roosevelt

Bogotá, Colombia

Actively Recruiting

12

CHALS-CCT UPR MScience

San Juan, Puerto Rico, 00935

Actively Recruiting

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Research Team

L

Laura Dugom, MPH

CONTACT

R

Robert Bowser, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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