ALS biomarker study aims to unlock disease clues
NCT ID NCT07260981
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study looked at 60 people — 30 with ALS and 30 healthy volunteers — to measure immune system and nerve damage markers in their blood and spinal fluid. The goal was to better understand the role of a specific immune pathway (IFN-alpha) in ALS. By linking these markers to patient symptoms, researchers hope to find better ways to diagnose and track the disease, and to identify new targets for future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help identify biological markers that improve diagnosis or track ALS progression, and may support future development of treatments targeting the immune system.
- What could go wrong
- This is an observational biomarker study, not a treatment trial. It is small (60 participants) and completed, so it will not directly lead to a new therapy. Results may not apply to all ALS patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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60 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
1. 30 ALS patients - 30 healthy controls 2. \> 18 years old 3. Age- and sex-matched controls 4. Inclusion/Exclusion criteria (see above) 5. ALS patients have been recruited and blood samples collected by Angelo Quattrini's team (UO neurology, UO Experimental pathology-INSPE) 6. Healthy control samples were purchased from BioIVT.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria for ALS patients: * Age equal or over 18 years old * ALS patients, diagnosed accordingly to the revised El Escorial Criteria Disease duration \<24 months from symptom onset. Inclusion criteria for controls * Age equal or over 18 years old * Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder. Exclusion criteria for ALS patients: * FVC \<60%; * nutritional or respiratory failure; Significant hepatic or chronic renal failure or any intervening infective (pneumonia, flu-like syndromes, urinary tract infections) or metabolic (acute renal failure, hyperosmolar hyperglycaemic state, severe hyponatremia) conditions present at the time of assessment that could potentially affect biomarker levels. * ALS patients exhibiting any of these conditions at the time of biofluid sampling as per the Case Report From (CRF) will be excluded from sample selection. Exclusion criteria for controls: * Significant hepatic or chronic renal failure or any intervening infective (pneumonia, flu-like syndromes, urinary tract infections) or metabolic (acute renal failure, hyperosmolar hyperglycaemic state, severe hyponatremia) conditions present at the time of assessment that could potentially affect biomarker levels. * Controls exhibiting any of these conditions at the time of biofluid sampling as per the Case Report From (CRF) will be excluded from sample selection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pioneer Life Sciences Cherrywood
Dublin, Ireland
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