Biomarkers of Synaptic Damage in Multiple Sclerosis

NCT03217396 | Recruiting DMC

• 1 other identifier: IRCCS Neuromed
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Parkinson Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease

Keywords

synaptic plasticity; neuroinflammation; neurodegeneration

Outcome Measures

Primary Outcomes (1)

• Identification of predictive biomarkers of SM using an ex vivo chimeric model

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

  September 01 2020

Secondary Outcomes (1)

• Identification of new therapeutic targets in MS.

  September 01 2020

Study Arms (3)

multiple sclerosis patients

lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis

Procedure: lumbar puncture

neurodegenerative disease patients

lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis

Procedure: lumbar puncture

control subjects

lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis

Procedure: lumbar puncture

Interventions

lumbar puncture PROCEDURE

lumbar puncture performed to detect OCB for diagnostic purposes

control subjects; multiple sclerosis patients; neurodegenerative disease patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromed IRCCS: lead
• IRCCS Multimedica: collaborator

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 33562569 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease; Amyotrophic Lateral Sclerosis; Alzheimer Disease; Neuroinflammatory Diseases; Nerve Degeneration

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Diego Centonze, MD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Centonze, MD

CONTACT

+39 3934444159; centonze@uniroma2.it

Mario Stampanoni Bassi, MD

CONTACT

+39 3460181370; mario_sb@hotmail.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: November 22, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)