NCT05137665Recruiting
Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 16 Nov 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Target ALS Foundation, Inc.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05137665
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jun 2021 to the primary completion date, 31 Dec 2031
- 12 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- ALS Participants:
- Age 18 or older.
- A diagnosis of ALS in accordance with Gold Coast criteria.
- Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening.
- Ability to provide informed consent and understand the purpose and risks of the study.
- Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
- Healthy Control Participants:
- Age 18 or older.
- No history of neurological disease, in the opinion of the Principal Investigator.
- No known ALS- associated genetic mutations at the time of consent.
- Ability to provide informed consent and understand the purpose and risks of the study.
- Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Roosevelt Coordinator of this site? Confirm its status | Bogotá | Colombia | Recruiting |
| CHALS-CCT UPR MScience Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Georgetown University Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.