Biomarkers of Synaptic Damage in Multiple Sclerosis

Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03217396

Enrollment

300

Registered

2017-07-14

Start date

2017-11-22

Completion date

2027-09-30

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson Disease

Keywords

synaptic plasticity, neuroinflammation, neurodegeneration

Brief 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. 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

Interventions

PROCEDURElumbar puncture

lumbar puncture performed to detect OCB for diagnostic purposes

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Male and female patients (age between 18 and 65 years) 2. Diagnosis of MS in accordance with McDonald's (2010 rev) criteria, 3. EDSS between 0 and 5.5 (included), 4. Patients able to provide informed consent to participation in the study

Exclusion criteria

1. Inability to provide informed written consent 2. Altered basal blood count 3. Pregnancy or lactation 4. Contraindications for the execution of magnetic resonance imaging with gadolinium 5. Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections

Design outcomes

Primary

Measure	Time frame	Description
Identification of predictive biomarkers of SM using an ex vivo chimeric model	September 01 2020	CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs

Secondary

Measure	Time frame	Description
Identification of new therapeutic targets in MS.	September 01 2020	CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs

Countries

Italy

Contacts

Primary ContactDiego Centonze, MD

centonze@uniroma2.it+39 3934444159

Backup ContactMario Stampanoni Bassi, MD

mario_sb@hotmail.it+39 3460181370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026