Amyotrophic Lateral Sclerosis (ALS)TUNEABLENCT07268833
Translating Single-cell Vulnerability Into Novel ALS Biomarkers and Therapeutic Targets: Towards a Liquid Nerve Biopsy
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Peripheral Neuropathies, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 4 sites in Italy.
Trial summary
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Peripheral Neuropathies
- How many people
- 400 participants
- Where
- 4 sitesItaly
- Study dates
- 24 Oct 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age equal or over 18 years old
- ALS patients, diagnosed accordingly to the revised El Escorial Criteria
- Disease duration <24 months from symptom onset.
- 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.
Show all 17Show fewer
- Age equal or over 18 years old
- Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder.
- 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.
- 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.
Who cannot join
- FVC <60%;
- nutritional or respiratory failure;
- significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
- significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Nilo Riva, MD, +39 02 2394, nilo.riva@istituto-besta.it
- Recruiting
IRCCS Ospedale San Raffaele SRL
Milan
Angelo Quattrini, MD, 0226435094, quattrini.angelo@hsr.it
Dario Bonomi, PHD, +39 0226435094, bonomi.dario@istituto-besta.it
- Recruiting
Azienda Ospedaliero Universitaria di Cagliari
Monserrato, California, 09042
Giuseppe Borghero, MD, + 39 3397886673, gborghero@aoucagliari.it
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Fiore Manganelli, MD, +39 3385290210, fiore.manganelli@unina.it
About this study
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original "PNS perspective" on disease pathogenesis.
Read the detailed description
The absence of specific biomarkers poses a significant impediment to the advancement of new treatments for amyotrophic lateral sclerosis (ALS), a severe and rapidly fatal neurodegenerative disease with no cure to date, defined by degeneration of motor neurons. Early pathological events, such as the selective damage of motor axons and the loss of neuromuscular connections, precede complete neurodegeneration and the manifestation of clinical symptoms. Therefore, we argue that understanding disease-related changes occurring in peripheral nerves is crucial for defining the underlying pathogenetic mechanisms. Preliminary data from our research team suggest that phosphorylated TDP-43, the pathological hallmark of ALS, forms aggregates in motor axons and Schwann cells of living ALS patients before the onset of axonal degeneration. However, peripheral nerves constitute complex multicellular tissues, and the specific contributions of individual cellular components to ALS pathology remain poorly understood. The overarching concept of this proposal is that distinct cell types within the nerve tissue (e.g., Schwann cells, endothelial cells, fibroblasts, macrophages) function as exquisite early detectors of motor neuron damage and initiate secondary responses that amplify neuropathology. These studies will steer the analysis of minimally invasive skin biopsies to uncover deregulated PNS signatures in ALS patients. Finally, candidate molecular targets reflecting cell-type-specific deregulation in the diseased nerve microenvironment will be screened in the biofluids of ALS patients and at-risk individuals from genetic ALS families, enabling the discovery of novel diagnostic and prognostic biomarkers. The integrative approach proposed in this study will elucidate the pathogenic mechanisms of ALS and establish a roadmap towards identifying potential therapeutic targets.
- Keywords
- ALS, Peripheral Neuropathies, Motor Neuron Disease, Biomarkers, Neurodegeneration, Nerve Biopsy, skin biopsy, Spatial Transcriptomics
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Peripheral Nervous System Diseases, Motor Neuron Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | ALS patients | |
| 2 | Neuropathy patients | |
| 3 | presymptomatic patients | |
| 4 | healthy controls | |
| 5 | Other neurodegenerative diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic ALS biomarkers
Throughout the study, we will validate, starting from transcriptomics data, novel diagnostic biomarker for an early diagnosis of ALS
Measured: 20 months
Secondary outcomes (2)
Prognostic biomarkers
explore novel prognostic biomarkers, able to reliably predict the time-course of ALS
Measured: 24 months
Therapeutic targets
identify molecular targets related to axonal degeneration for potential therapeutic intervention
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start24 Oct 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Cagliari, IRCCS San Raffaele, Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268833
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12377651
- Acronym
- TUNEABLE
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rocha MC, Pousinha PA, Correia AM, Sebastiao AM, Ribeiro JA. Early changes of neuromuscular transmission in the SOD1(G93A) mice model of ALS start long before motor symptoms onset. PLoS One. 2013 Sep 5;8(9):e73846. doi: 10.1371/journal.pone.0073846. eCollection 2013.
PubMed 24040091Riva N, Iannaccone S, Corbo M, Casellato C, Sferrazza B, Lazzerini A, Scarlato M, Cerri F, Previtali SC, Nobile-Orazio E, Comi G, Quattrini A. Motor nerve biopsy: clinical usefulness and histopathological criteria. Ann Neurol. 2011 Jan;69(1):197-201. doi: 10.1002/ana.22110. Epub 2010 Nov 12.
PubMed 21280090Riva N, Gentile F, Cerri F, Gallia F, Podini P, Dina G, Falzone YM, Fazio R, Lunetta C, Calvo A, Logroscino G, Lauria G, Corbo M, Iannaccone S, Chio A, Lazzerini A, Nobile-Orazio E, Filippi M, Quattrini A. Phosphorylated TDP-43 aggregates in peripheral motor nerves of patients with amyotrophic lateral sclerosis. Brain. 2022 Mar 29;145(1):276-284. doi: 10.1093/brain/awab285.
PubMed 35076694Riva N, Clarelli F, Domi T, Cerri F, Gallia F, Trimarco A, Brambilla P, Lunetta C, Lazzerini A, Lauria G, Taveggia C, Iannaccone S, Nobile-Orazio E, Comi G, D'Antonio M, Martinelli-Boneschi F, Quattrini A. Unraveling gene expression profiles in peripheral motor nerve from amyotrophic lateral sclerosis patients: insights into pathogenesis. Sci Rep. 2016 Dec 16;6:39297. doi: 10.1038/srep39297.
PubMed 27982123Nolano M, Provitera V, Manganelli F, Iodice R, Caporaso G, Stancanelli A, Marinou K, Lanzillo B, Santoro L, Mora G. Non-motor involvement in amyotrophic lateral sclerosis: new insight from nerve and vessel analysis in skin biopsy. Neuropathol Appl Neurobiol. 2017 Feb;43(2):119-132. doi: 10.1111/nan.12332. Epub 2016 Jul 7.
PubMed 27288647Gentile F, Scarlino S, Falzone YM, Lunetta C, Tremolizzo L, Quattrini A, Riva N. The Peripheral Nervous System in Amyotrophic Lateral Sclerosis: Opportunities for Translational Research. Front Neurosci. 2019 Jun 25;13:601. doi: 10.3389/fnins.2019.00601. eCollection 2019.
PubMed 31293369Fischer LR, Culver DG, Tennant P, Davis AA, Wang M, Castellano-Sanchez A, Khan J, Polak MA, Glass JD. Amyotrophic lateral sclerosis is a distal axonopathy: evidence in mice and man. Exp Neurol. 2004 Feb;185(2):232-40. doi: 10.1016/j.expneurol.2003.10.004.
PubMed 14736504Casiraghi V, Milone I, Brusati A, Peverelli S, Doretti A, Poletti B, Maderna L, Morelli C, Ticozzi N, Silani V, Verde F, Ratti A. Quantification of serum TDP-43 and neurofilament light chain in patients with amyotrophic lateral sclerosis stratified by UNC13A genotype. J Neurol Sci. 2024 Nov 15;466:123210. doi: 10.1016/j.jns.2024.123210. Epub 2024 Sep 2.
PubMed 39241471Brodovitch A, Boucraut J, Delmont E, Parlanti A, Grapperon AM, Attarian S, Verschueren A. Combination of serum and CSF neurofilament-light and neuroinflammatory biomarkers to evaluate ALS. Sci Rep. 2021 Jan 12;11(1):703. doi: 10.1038/s41598-020-80370-6.
PubMed 33436881Bhat GP, Maurizio A, Motta A, Podini P, Diprima S, Malpighi C, Brambilla I, Martins L, Badaloni A, Boselli D, Bianchi F, Pellegatta M, Genua M, Ostuni R, Del Carro U, Taveggia C, de Pretis S, Quattrini A, Bonanomi D. Structured wound angiogenesis instructs mesenchymal barrier compartments in the regenerating nerve. Neuron. 2024 Jan 17;112(2):209-229.e11. doi: 10.1016/j.neuron.2023.10.025. Epub 2023 Nov 15.
PubMed 37972594Barrientos SA, Martinez NW, Yoo S, Jara JS, Zamorano S, Hetz C, Twiss JL, Alvarez J, Court FA. Axonal degeneration is mediated by the mitochondrial permeability transition pore. J Neurosci. 2011 Jan 19;31(3):966-78. doi: 10.1523/JNEUROSCI.4065-10.2011.
PubMed 21248121
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Single-cell Vulnerability Into Novel ALS Biomarkers and Therapeutic Targets: Towards a Liquid Nerve Biopsy
- ClinicalTrials.gov ID
- NCT07268833
- Acronym / sponsor ID
- TUNEABLE / PNRR-MCNT2-2023-12377651
- Keywords
- ALS, Peripheral Neuropathies, Motor Neuron Disease, Biomarkers, Neurodegeneration, Nerve Biopsy, skin biopsy, Spatial Transcriptomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria di Cagliari, IRCCS San Raffaele, Federico II University
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original "PNS perspective" on disease pathogenesis.
Detailed description
The absence of specific biomarkers poses a significant impediment to the advancement of new treatments for amyotrophic lateral sclerosis (ALS), a severe and rapidly fatal neurodegenerative disease with no cure to date, defined by degeneration of motor neurons. Early pathological events, such as the selective damage of motor axons and the loss of neuromuscular connections, precede complete neurodegeneration and the manifestation of clinical symptoms. Therefore, we argue that understanding disease-related changes occurring in peripheral nerves is crucial for defining the underlying pathogenetic mechanisms. Preliminary data from our research team suggest that phosphorylated TDP-43, the pathological hallmark of ALS, forms aggregates in motor axons and Schwann cells of living ALS patients before the onset of axonal degeneration. However, peripheral nerves constitute complex multicellular tissues, and the specific contributions of individual cellular components to ALS pathology remain poorly understood. The overarching concept of this proposal is that distinct cell types within the nerve tissue (e.g., Schwann cells, endothelial cells, fibroblasts, macrophages) function as exquisite early detectors of motor neuron damage and initiate secondary responses that amplify neuropathology. These studies will steer the analysis of minimally invasive skin biopsies to uncover deregulated PNS signatures in ALS patients. Finally, candidate molecular targets reflecting cell-type-specific deregulation in the diseased nerve microenvironment will be screened in the biofluids of ALS patients and at-risk individuals from genetic ALS families, enabling the discovery of novel diagnostic and prognostic biomarkers. The integrative approach proposed in this study will elucidate the pathogenic mechanisms of ALS and establish a roadmap towards identifying potential therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –ALS patients |
| 2 | – | –Neuropathy patients |
| 3 | – | –presymptomatic patients |
| 4 | – | –healthy controls |
| 5 | – | –Other neurodegenerative diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (17 listed)
- Age equal or over 18 years old
- ALS patients, diagnosed accordingly to the revised El Escorial Criteria
- Disease duration <24 months from symptom onset.
- 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
Key exclusion criteria (4 listed)
- FVC <60%;
- nutritional or respiratory failure;
- significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
- significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic ALS biomarkers
Time frame: 20 months
Throughout the study, we will validate, starting from transcriptomics data, novel diagnostic biomarker for an early diagnosis of ALS
2 secondary outcomes
Prognostic biomarkers
Time frame: 24 months
Therapeutic targets
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 24040091Rocha MC, Pousinha PA, Correia AM, Sebastiao AM, Ribeiro JA. Early changes of neuromuscular transmission in the SOD1(G93A) mice model of ALS start long before motor symptoms onset. PLoS One. 2013 Sep 5;8(9):e73846. doi: 10.1371/journal.pone.0073846. eCollection 2013.
- Background: PubMed 21280090Riva N, Iannaccone S, Corbo M, Casellato C, Sferrazza B, Lazzerini A, Scarlato M, Cerri F, Previtali SC, Nobile-Orazio E, Comi G, Quattrini A. Motor nerve biopsy: clinical usefulness and histopathological criteria. Ann Neurol. 2011 Jan;69(1):197-201. doi: 10.1002/ana.22110. Epub 2010 Nov 12.
- Background: PubMed 35076694Riva N, Gentile F, Cerri F, Gallia F, Podini P, Dina G, Falzone YM, Fazio R, Lunetta C, Calvo A, Logroscino G, Lauria G, Corbo M, Iannaccone S, Chio A, Lazzerini A, Nobile-Orazio E, Filippi M, Quattrini A. Phosphorylated TDP-43 aggregates in peripheral motor nerves of patients with amyotrophic lateral sclerosis. Brain. 2022 Mar 29;145(1):276-284. doi: 10.1093/brain/awab285.
- Background: PubMed 27982123Riva N, Clarelli F, Domi T, Cerri F, Gallia F, Trimarco A, Brambilla P, Lunetta C, Lazzerini A, Lauria G, Taveggia C, Iannaccone S, Nobile-Orazio E, Comi G, D'Antonio M, Martinelli-Boneschi F, Quattrini A. Unraveling gene expression profiles in peripheral motor nerve from amyotrophic lateral sclerosis patients: insights into pathogenesis. Sci Rep. 2016 Dec 16;6:39297. doi: 10.1038/srep39297.
- Background: PubMed 27288647Nolano M, Provitera V, Manganelli F, Iodice R, Caporaso G, Stancanelli A, Marinou K, Lanzillo B, Santoro L, Mora G. Non-motor involvement in amyotrophic lateral sclerosis: new insight from nerve and vessel analysis in skin biopsy. Neuropathol Appl Neurobiol. 2017 Feb;43(2):119-132. doi: 10.1111/nan.12332. Epub 2016 Jul 7.
- Background: PubMed 31293369Gentile F, Scarlino S, Falzone YM, Lunetta C, Tremolizzo L, Quattrini A, Riva N. The Peripheral Nervous System in Amyotrophic Lateral Sclerosis: Opportunities for Translational Research. Front Neurosci. 2019 Jun 25;13:601. doi: 10.3389/fnins.2019.00601. eCollection 2019.
- Background: PubMed 14736504Fischer LR, Culver DG, Tennant P, Davis AA, Wang M, Castellano-Sanchez A, Khan J, Polak MA, Glass JD. Amyotrophic lateral sclerosis is a distal axonopathy: evidence in mice and man. Exp Neurol. 2004 Feb;185(2):232-40. doi: 10.1016/j.expneurol.2003.10.004.
- Background: PubMed 39241471Casiraghi V, Milone I, Brusati A, Peverelli S, Doretti A, Poletti B, Maderna L, Morelli C, Ticozzi N, Silani V, Verde F, Ratti A. Quantification of serum TDP-43 and neurofilament light chain in patients with amyotrophic lateral sclerosis stratified by UNC13A genotype. J Neurol Sci. 2024 Nov 15;466:123210. doi: 10.1016/j.jns.2024.123210. Epub 2024 Sep 2.
- Background: PubMed 33436881Brodovitch A, Boucraut J, Delmont E, Parlanti A, Grapperon AM, Attarian S, Verschueren A. Combination of serum and CSF neurofilament-light and neuroinflammatory biomarkers to evaluate ALS. Sci Rep. 2021 Jan 12;11(1):703. doi: 10.1038/s41598-020-80370-6.
- Background: PubMed 37972594Bhat GP, Maurizio A, Motta A, Podini P, Diprima S, Malpighi C, Brambilla I, Martins L, Badaloni A, Boselli D, Bianchi F, Pellegatta M, Genua M, Ostuni R, Del Carro U, Taveggia C, de Pretis S, Quattrini A, Bonanomi D. Structured wound angiogenesis instructs mesenchymal barrier compartments in the regenerating nerve. Neuron. 2024 Jan 17;112(2):209-229.e11. doi: 10.1016/j.neuron.2023.10.025. Epub 2023 Nov 15.
- Background: PubMed 21248121Barrientos SA, Martinez NW, Yoo S, Jara JS, Zamorano S, Hetz C, Twiss JL, Alvarez J, Court FA. Axonal degeneration is mediated by the mitochondrial permeability transition pore. J Neurosci. 2011 Jan 19;31(3):966-78. doi: 10.1523/JNEUROSCI.4065-10.2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azienda Ospedaliero Universitaria di Cagliari
Monserrato, Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Peripheral Neuropathies, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic ALS biomarkers (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07268833, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.