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

NCT05137665 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-11-21

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Target ALS Foundation, Inc.

    lead OTHER

Principal Investigators

  • Laura Dugom, MPH · Target ALS Foundation, Inc.

  • Amy Easton, PhD · Target ALS Foundation, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • United States
  • Colombia
  • Puerto Rico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05137665 on ClinicalTrials.gov