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Biomarkers of Synaptic Damage in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03217396
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
IRCCS Multimedica
Information provided by (Responsible Party):
Neuromed IRCCS

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Parkinson Disease Amyotrophic Lateral Sclerosis Alzheimer Disease Procedure: lumbar puncture

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 [4], NGFB [15], PDGFA [7], 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 Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
multiple sclerosis patients
lumbar puncture, mRNAs quantification in blood and CSF samples, SNPs analysis
 Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes
neurodegenerative disease patients
lumbar puncture, mRNAs quantification in blood and CSF samples, SNPs analysis
 Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes
control subjects
lumbar puncture, mRNAs quantification in blood and CSF samples, SNPs analysis
 Procedure: lumbar puncture
lumbar puncture performed to detect OCB for diagnostic purposes


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 mRNAs


Secondary Outcome Measures :
  1. Identification of new therapeutic targets in MS. [ Time Frame: September 01 2020 ]
    CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and mRNAs


Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217396


Locations
Italy
IRCCS Neuromed Recruiting
Pozzilli, Isernia, Italy, 86077
Contact: Stefania Passarelli    +39 0865.915217    direzionescientifica@neuromed.it   
Sponsors and Collaborators
Neuromed IRCCS
IRCCS Multimedica
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03217396     History of Changes
Other Study ID Numbers: IRCCS Neuromed
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neuromed IRCCS:
synaptic plasticity
neuroinflammation
neurodegeneration

Additional relevant MeSH terms:
Sclerosis
Parkinson Disease
Multiple Sclerosis
Alzheimer Disease
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases