Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS) (BIO_ALS-01)
A Multicenter Study for the Validation of ALS Biomarkers
Sponsor: ALS Association
Listed as NCT00677768, this observational or N/A phase trial focuses on Amyotrophic Lateral Sclerosis and Hereditary Spastic Paraparesis and remains completed. Sponsored by ALS Association, it has been updated 12 times since 2008, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers with neurological diseases other than ALS. These changes are called biomarkers. Biomarkers for ALS have been found in blood collected in earlier phases of this study. Biomarkers are non-genetic elements in your blood that may help to make diagnosing ALS easier. In the next phase, comparison of these changes in the blood of volunteers with ALS and without ALS will be used to confirm these biomarkers and to develop a tool to diagnose and monitor progression of ALS.
Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers with neurological diseases other than ALS. These changes are called biomarkers. Biomarkers for ALS have been found in blood collected in earlier phases of this study. Biomarkers are non-genetic elements in your blood that may help to make diagnosing ALS easier. In the next phase, comparison of these changes in the blood of volunteers with ALS and without ALS will be used to confirm these biomarkers and to develop a tool to diagnose and monitor progression of ALS.
Status Flow
Change History
12 versions recorded-
Jan 2026 — Present [monthly]
Completed
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Sep 2025 — Present [monthly]
Completed
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Sep 2024 — Sep 2025 [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Dec 2021 — Jul 2024 [monthly]
Completed
▶ Show 7 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
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Jun 2018 — Nov 2020 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
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Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Completed NA
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Jan 2017 — Aug 2017 [monthly]
Completed NA
First recorded
Apr 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- ALS Association
- ALS Therapy Alliance
- Massachusetts General Hospital
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health (NIH)
For direct contact, visit the study record on ClinicalTrials.gov .