Multiple SclerosisNCT03217396
Biomarkers of Synaptic Damage in Multiple Sclerosis
An observational study of Multiple Sclerosis and Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- lumbar puncture
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2017to 30 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients recruited within the Neurology Unit, IRCCS Neuromed. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited as control group.
Who may be able to join
- Male and female patients (age between 18 and 65 years)
- Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
- EDSS between 0 and 5.5 (included),
- Patients able to provide informed consent to participation in the study
Who cannot join
- Inability to provide informed written consent
- Altered basal blood count
- Pregnancy or lactation
- Contraindications for the execution of magnetic resonance imaging with gadolinium
- Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli, Isernia, 86077
Stefania Passarelli, +39 0865.915217, direzionescientifica@neuromed.it
About this study
Official title: Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.
Read the detailed description
Blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. Subsequently, the levels of microRNAs, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (Objective 1) will be determined. Furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of MS, using the patch-clamp technique (Objective 2). Genotyping studies will be conducted in order to identify single nucleotide polymorphisms (SNPs) in coding and / or regulating regions of genes (microRNAs or proteins) involved in alterations of the synaptic transmission of MS and its murine experimental model (i.e. SLC1A3, NGFB, PDGFA, etc.), which correlate with specific clinical parameters (i.e. EDSS, BREMS, disease progression index, MS type, disease activity, etc.) and with the levels of potential biomarkers identified
- Being tested
- lumbar puncture
- Keywords
- synaptic plasticity, neuroinflammation, neurodegeneration
- Medical subject headings
- Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis, Alzheimer Disease, Neuroinflammatory Diseases, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar punctureProcedure or surgery
lumbar puncture performed to detect OCB for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis patients | lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis Receives: Procedure: lumbar puncture | |
| neurodegenerative disease patients | lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis Receives: Procedure: lumbar puncture | |
| control subjects | lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis Receives: Procedure: lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive biomarkers of SM using an ex vivo chimeric model
CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
Measured: September 01 2020
Secondary outcomes (1)
Identification of new therapeutic targets in MS.
CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
Measured: September 01 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start22 Nov 2017
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Multimedica
- Responsible party
- Principal investigator, Mario Stampanoni Bassi, Neuromed IRCCS
- Investigators
- Diego Centonze, MD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217396
- Sponsor's protocol ID
- IRCCS Neuromed
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2017
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mandolesi G, Rizzo FR, Balletta S, Stampanoni Bassi M, Gilio L, Guadalupi L, Nencini M, Moscatelli A, Ryan CP, Licursi V, Dolcetti E, Musella A, Gentile A, Fresegna D, Bullitta S, Caioli S, Vanni V, Sanna K, Bruno A, Buttari F, Castelli C, Presutti C, De Santa F, Finardi A, Furlan R, Centonze D, De Vito F. The microRNA let-7b-5p Is Negatively Associated with Inflammation and Disease Severity in Multiple Sclerosis. Cells. 2021 Feb 5;10(2):330. doi: 10.3390/cells10020330.
PubMed 33562569
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
- ClinicalTrials.gov ID
- NCT03217396
- Acronym / sponsor ID
- IRCCS Neuromed
- Keywords
- synaptic plasticity, neuroinflammation, neurodegeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- IRCCS Multimedica
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jul 2017 (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.
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.
Detailed description
Blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. Subsequently, the levels of microRNAs, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (Objective 1) will be determined. Furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of MS, using the patch-clamp technique (Objective 2). Genotyping studies will be conducted in order to identify single nucleotide polymorphisms (SNPs) in coding and / or regulating regions of genes (microRNAs or proteins) involved in alterations of the synaptic transmission of MS and its murine experimental model (i.e. SLC1A3, NGFB, PDGFA, etc.), which correlate with specific clinical parameters (i.e. EDSS, BREMS, disease progression index, MS type, disease activity, etc.) and with the levels of potential biomarkers identified
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis patients | – | Procedure: lumbar puncturelumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis |
| neurodegenerative disease patients | – | Procedure: lumbar puncturelumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis |
| control subjects | – | Procedure: lumbar puncturelumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients recruited within the Neurology Unit, IRCCS Neuromed. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited as control group.
Key inclusion criteria (4 listed)
- Male and female patients (age between 18 and 65 years)
- Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
- EDSS between 0 and 5.5 (included),
- Patients able to provide informed consent to participation in the study
Key exclusion criteria (5 listed)
- Inability to provide informed written consent
- Altered basal blood count
- Pregnancy or lactation
- Contraindications for the execution of magnetic resonance imaging with gadolinium
- Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar puncturelumbar puncture performed to detect OCB for diagnostic purposes | Procedure or surgery | control subjects, multiple sclerosis patients, neurodegenerative disease patients |
Primary outcome
Identification of predictive biomarkers of SM using an ex vivo chimeric model
Time frame: September 01 2020
CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
1 secondary outcome
Identification of new therapeutic targets in MS.
Time frame: September 01 2020
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 28 Oct 2022.
- Derived from this study: PubMed 33562569Mandolesi G, Rizzo FR, Balletta S, Stampanoni Bassi M, Gilio L, Guadalupi L, Nencini M, Moscatelli A, Ryan CP, Licursi V, Dolcetti E, Musella A, Gentile A, Fresegna D, Bullitta S, Caioli S, Vanni V, Sanna K, Bruno A, Buttari F, Castelli C, Presutti C, De Santa F, Finardi A, Furlan R, Centonze D, De Vito F. The microRNA let-7b-5p Is Negatively Associated with Inflammation and Disease Severity in Multiple Sclerosis. Cells. 2021 Feb 5;10(2):330. doi: 10.3390/cells10020330.
- Individual participant dataSharing planned: No
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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.
Diego Centonze, MD principal investigator
IRCCS Neuromed
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 Multiple Sclerosis and Parkinson Disease, run by Neuromed IRCCS at 1 site 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 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: looking for participants now, as of the sponsor's last update on 28 Oct 2022. 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 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?
Contact Diego Centonze, MD (+39 3934444159, centonze@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive biomarkers of SM using an ex vivo chimeric model (time frame: September 01 2020). 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 NCT03217396, which also lists 1 linked publication.
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 28 Oct 2022.