Liquid nerve biopsy could unlock ALS secrets
NCT ID NCT07268833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is collecting nerve samples and biofluids from 400 people with ALS or peripheral neuropathies to find biological markers for early diagnosis and disease tracking. By analyzing individual cells, researchers hope to identify molecular changes that happen before symptoms appear. The goal is to develop reliable tests and uncover 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 could lead to reliable tests for earlier ALS diagnosis and better ways to track disease progression, and may point to new treatment targets.
- What could go wrong
- This is an observational study, not a treatment trial. It is still in early stages, and the biomarkers discovered may not prove useful in practice or lead directly to therapies.
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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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
Number of patients projected for: * the entire study: 400 patients * each treatment group: ALS 150, HC 40, non-ALS neurodegenerative 60, non-ALS neuromuscular diseases 50, Indipendent cohort of ALS Sardinian patients 100.
- 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. Exclusion Criteria for als patients: * FVC \<60%; * nutritional or respiratory failure; * significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels. Inclusion criteria for ALS pre-symptomatic patients * Age equal or over 18 years old * Patients with genetic defined susceptibility to ALS and one or more strict relative affected from ALS Exclusion criteria for ALS pre-symptomatic patients * significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels. Inclusion criteria for controls * Age equal or over 18 years old * Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder. Exclusion criteria for controls • significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels. Inclusion criteria for non ALS neurodegenerative patients * Age equal or over 18 years old * For AD: Diagnosis according to 2018 NIA-AA Framework for Alzheimer's Disease * For FTD: Diagnosis according to 2011 International Behavioural Variant FTD Criteria Consortium * For PD: Diagnosis according to 2015 Movement Disorder Society criteria * For DLB: Diagnosis according to 2017 Fourth Consensus Report of the DLB Consortium Exclusion criteria for non ALS neurodegenerative patients * significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels. Inclusion criteria for neuromuscular disease patients * Age equal or over 18 years old * Presence of axonal or demyelinating neuropathy Exclusion criteria for neuromuscular patients * significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliera Universitaria Federico II
RECRUITINGNaples, 80131, Italy
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Azienda Ospedaliero Universitaria di Cagliari
RECRUITINGMonserrato, California, 09042, Italy
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Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITINGMilan, Italy
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IRCCS Ospedale San Raffaele SRL
RECRUITINGMilan, Italy
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