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Recruiting NCT03217396

Biomarkers of Synaptic Damage in Multiple Sclerosis

— Observational Multiple Sclerosis Parkinson Disease Amyotrophic Lateral Sclerosis Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lumbar puncture.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis, Alzheimer Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure lumbar puncture
    lumbar puncture performed to detect OCB for diagnostic purposes

Primary outcome measures

  • Identification of predictive biomarkers of SM using an ex vivo chimeric model [Time frame: September 01 2020]
Secondary outcome measures (1)
  • Identification of new therapeutic targets in MS. [Time frame: September 01 2020]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • IRCCS Neuromed — Pozzilli

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 Mu PMID 33562569

Identifiers

NCT: NCT03217396 · IRCCS Neuromed

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗