ALS - Amyotrophic Lateral SclerosisNCT07260981
Comprehensive Biomarker Profiling of the IFN-α Pathway in Amyotrophic Lateral Sclerosis Patient Biofluids
An observational study of ALS - Amyotrophic Lateral Sclerosis, run by Ulysses Neuroscience LTD at 1 site in Ireland.
Trial summary
ALS is characterized by significant genetic, clinical, and biological heterogeneity. The heritability of ALS is approximately 50%, and variants in more than 200 genes have been associated with the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALS - Amyotrophic Lateral Sclerosis
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2023to 18 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
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
- Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
ALS is characterized by significant genetic, clinical, and biological heterogeneity. The heritability of ALS is approximately 50%, and variants in more than 200 genes have been associated with the disease. Clinical features are highly variable for most variants, likely due to interactions with other modifier genes and environmental factors. Mutations in groups of genes belonging to specific ALS pathomechanisms may be associated with distinct phenotypes, but better correlations with clinical and biomarker profiles are still needed. Clinically, patients show significant variability in disease onset and progression, as well as in motor and cognitive phenotypes. Several clinical, neurophysiological, neuropsychological, and neuroradiological measures have been developed to account for this variability, but neurochemical biomarkers may represent an ideal tool to identify homogeneous patient subgroups.
The most extensively studied neurochemical biomarkers in ALS are neurofilaments, which are released from degenerating motor neurons into biological fluids and have diagnostic and prognostic value. Other potential biomarkers of neuronal damage in ALS include tau (associated with shorter survival), UCHL1, and TDP-43 (both elevated in ALS patients). Microglial and astrocytic involvement in ALS pathogenesis can be investigated by measuring MCP-1 and GFAP, respectively.
Read more
Considering the growing evidence implicating IFN-alpha involvement in ALS pathogenesis, we aim to comprehensively profile cytokines, neuroinflammatory markers, and analytes related to neurodegeneration in the plasma and cerebrospinal fluid (CSF) of clinically characterized ALS patients and matched healthy controls.
This study will support the validation of IFN-alpha pathway activation as a therapeutic target and explore its association with disease phenotype and progression. Furthermore, correlations between biomarker levels and available clinical data will provide insights into potential diagnostic and prognostic biomarkers for ALS, thereby facilitating future therapeutic development.
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Nf-L, GFAP, pTau (T181)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
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 |
|---|---|---|
| ALS patients | ALS patients, diagnosed accordingly to the revised El Escorial Criteria | |
| Healthy controls | Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling of neurodegenerative and inflammatory markers in in ALS plasma and CSF
Ulysses Neuroscience Ltd. will perform electrochemiluminescence sandwich ELISA using the Meso-Scale Discovery platform (MESO QuickPlex SQ 120 instrument and analyzed by Discovery Workbench 4.0 software). Data will be analysed as ALS vs healthy control as raw values of each analyte in the samples (pg/mL) and graphed using GraphPad Prism v.9.
Specific analytes to be measured include:
IFN-α2a, IFN-β, IL-12/IL-23p40, CXCL10/IP10, CCL2/MCP1, IFN-γ, IL-6, IL-8, IL-13, TNF-α, CCL5/RANTES, TDP-43, GFAP, Neurofilament L, Tau [Total], pTau T181, pTau T217, pTau T231
Measured: As it is a retrospective study and only biomarker analyses will take place, we plan to start the analysis in October and conclude it in December 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Mar 2023
- Primary completion18 Jan 2025
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS - Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulysses Neuroscience LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Quattrini, IRCCS San Raffaele
- Investigators
- Massimiliano Bianchi, Principal investigator, Ulysses Neuroscience LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260981
- Sponsor's protocol ID
- UNL074
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared because it is not relevant to the interpretation or consideration of the data. The controls and ALS patients were fully age- and gender-matched and so the data can be considered without the need to return to patient ID's or demographic/clinical data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Biomarker Profiling of the IFN-α Pathway in Amyotrophic Lateral Sclerosis Patient Biofluids
- ClinicalTrials.gov ID
- NCT07260981
- Acronym / sponsor ID
- UNL074
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Nf-L, GFAP, pTau (T181)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ulysses Neuroscience LTDUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 3 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.
ALS is characterized by significant genetic, clinical, and biological heterogeneity. The heritability of ALS is approximately 50%, and variants in more than 200 genes have been associated with the disease. Clinical features are highly variable for most variants, likely due to interactions with other modifier genes and environmental factors. Mutations in groups of genes belonging to specific ALS pathomechanisms may be associated with distinct phenotypes, but better correlations with clinical and biomarker profiles are still needed. Clinically, patients show significant variability in disease onset and progression, as well as in motor and cognitive phenotypes. Several clinical, neurophysiological, neuropsychological, and neuroradiological measures have been developed to account for this variability, but neurochemical biomarkers may represent an ideal tool to identify homogeneous patient subgroups.
The most extensively studied neurochemical biomarkers in ALS are neurofilaments, which are released from degenerating motor neurons into biological fluids and have diagnostic and prognostic value. Other potential biomarkers of neuronal damage in ALS include tau (associated with shorter survival), UCHL1, and TDP-43 (both elevated in ALS patients). Microglial and astrocytic involvement in ALS pathogenesis can be investigated by measuring MCP-1 and GFAP, respectively.
Considering the growing evidence implicating IFN-alpha involvement in ALS pathogenesis, we aim to comprehensively profile cytokines, neuroinflammatory markers, and analytes related to neurodegeneration in the plasma and cerebrospinal fluid (CSF) of clinically characterized ALS patients and matched healthy controls.
This study will support the validation of IFN-alpha pathway activation as a therapeutic target and explore its association with disease phenotype and progression. Furthermore, correlations between biomarker levels and available clinical data will provide insights into potential diagnostic and prognostic biomarkers for ALS, thereby facilitating future therapeutic development.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | –ALS patients, diagnosed accordingly to the revised El Escorial Criteria |
| Healthy controls | – | –Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 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
- Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder.
Key exclusion criteria (5 listed)
- 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.
- 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.
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
Profiling of neurodegenerative and inflammatory markers in in ALS plasma and CSF
Time frame: As it is a retrospective study and only biomarker analyses will take place, we plan to start the analysis in October and conclude it in December 2025.
Ulysses Neuroscience Ltd. will perform electrochemiluminescence sandwich ELISA using the Meso-Scale Discovery platform (MESO QuickPlex SQ 120 instrument and analyzed by Discovery Workbench 4.0 software). Data will be analysed as ALS vs healthy control as raw values of each analyte in the samples (pg/mL) and graphed using GraphPad Prism v.9. Specific analytes to be measured include: IFN-α2a, IFN-β, IL-12/IL-23p40, CXCL10/IP10, CCL2/MCP1, IFN-γ, IL-6, IL-8, IL-13, TNF-α, CCL5/RANTES, TDP-43, GFAP, Neurofilament L, Tau [Total], pTau T181, pTau T217, pTau T231
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No. Individual data will not be shared because it is not relevant to the interpretation or consideration of the data. The controls and ALS patients were fully age- and gender-matched and so the data can be considered without the need to return to patient ID's or demographic/clinical data.
Related trials for ALS - Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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. This study is not recruiting at the moment.
Massimiliano Bianchi principal investigator
Ulysses Neuroscience LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS - Amyotrophic Lateral Sclerosis, run by Ulysses Neuroscience LTD at 1 site in Ireland.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 3 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 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiling of neurodegenerative and inflammatory markers in in ALS plasma and CSF (time frame: As it is a retrospective study and only biomarker analyses will take place, we plan to start the analysis in October and conclude it in December 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.