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NCT Number: NCT03217396

Biomarkers of Synaptic Damage in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Alzheimer Disease Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inflammation Mental Disorders Metabolic Diseases Motor Neuron Disease Movement Disorders Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Spinal Cord Diseases Synucleinopathies TDP-43 Proteinopathies Tauopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Puncture

Procedure

lumbar puncture performed to detect OCB for diagnostic purposes

Primary outcomes

  1. 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

Secondary outcomes

  1. Identification of new therapeutic targets in MS.

    Time frame: September 01 2020

    CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Centonze, MD

CONTACT

[email protected]

+39 3934444159

Mario Stampanoni Bassi, MD

CONTACT

[email protected]

+39 3460181370

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Collaborators

  • IRCCS Multimedica

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2017
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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