Biomarkers of Synaptic Damage in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNeuromed IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide informed written consent
Altered basal blood count
Pregnancy or lactation
Contraindications for the execution of magnetic resonance imaging with gadolinium
Trial 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.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
lumbar puncture
Procedure/Surgerylumbar puncture performed to detect OCB for diagnostic purposes
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: multiple sclerosis patients1 intervention
Group B: neurodegenerative disease patients1 intervention
Group C: control subjects1 intervention
Trial outcomes
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
Time frame
September 01 2020Secondary outcomes
1
Identification of new therapeutic targets in MS.
CSF concentrations of: neurofilaments, beta amyloid, tau protein, inflammatory cytokines and microRNAs
Time frame
September 01 2020Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Neuromed IRCCS
Lead sponsor
IRCCS Multimedica
Collaborator
Source ClinicalTrials.gov