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

Study Purpose:

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.

Study Status:



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

Study Type:


Type of Intervention:


Intervention Name:






Study Chair(s)/Principal Investigator(s):

Diego Centonze, MD, IRCCS Neuromed ID:


Neals Affiliated?


Coordinating Center Contact Information

Diego Centonze, MD / email hidden; JavaScript is required / +39 3934444159

Full Study Summary:

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 Sponsor:

Neuromed IRCCS

Estimated Enrollment:


Estimated Study Start Date:

11 / 22 / 2017

Estimated Study Completion Date:

09 / 30 / 2027

Posting Last Modified Date:

10 / 28 / 2022

Date Study Added to

07 / 14 / 2017

Minimum Age:

18 Years

Maximum Age:

65 Years

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

IRCCS Neuromed | Recruiting

Stefania Passarelli / +39 0865.915217 / email hidden; JavaScript is required

Pozzilli, Isernia 86077