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NCT07769294 · ClinicalTrials.gov record · last posted 2026-08-17

PLasmatic Extracellular Vesicles AS Biomarkers of nEural Tissue Damage

Study acronym: PLEASE
StatusNot Yet Recruiting
PhaseNot specified
Started2026-09-15
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from the ClinicalTrials.gov record
Recently proposed central nervous system damage biomarkers detectable in biofluids, such as neurofilament light chain (NfL) have several limits, including a lack in specificity and a kinetic that does not allow them to be used as outcome measures in clinical trials for neurodegenerative diseases such as the progressive forms of multiple sclerosis (MS) or the sequelae of stroke. Our team has pioneered the detection of central nervous system (CNS) extracellular vesicles (EVs) as biomarkers in MS and Alzheimer's Disease. If EVs are not the best solution themselves, we propose also to investigate their content to reveal potential new biomarkers having the same significance and an easier detection technology. Thus, we propose here to set-up front line technologies to detect EVs of CNS origin, or their content, in the plasma of persons affected by MS or by stroke to find better ways to monitor ongoing neurodegenerative processes and therefore allow easier development of new treatments.
Trial Details
NCT Number NCT07769294
Lead Sponsor Roberto Furlan
Collaborators: IRCCS Santa Lucia Foundation, Rome
Conditions Multiple Sclerosis, Stroke
Enrollment 60 participants
Start Date 2026-09-15
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-17