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Longitudinal Profiling of Plasma-Derived Glial Extracellular Vesicles in Alzheimer's Disease

NCT07803055 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-09-03

No results posted yet for this study

Summary

This project aims to longitudinally profile plasma-derived GDEVs and plasma biomarkers of neuroinflammation across three stages of the AD continuum (Subjective Cognitive Decline, Mild Cognitive Impairment, and Alzheimer's Dementia), exploring their association with biomarkers of amyloidopathy, tauopathy and neurodegeneration, cognitive status and clinical outcome over time. Moreover, GDEVs - collected from subjects at different disease stages - will be used to treat human neurons derived from induced pluripotent stem cells (iPSCs) from healthy controls in order to assess the induced differential neurotoxic or priming effects. This dual translational approach may help identify early pathogenic signatures of neuroinflammation and elucidate their role in disease progression.

Conditions

  • Subjective Cognitive Decline (SCD)
  • Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
  • Alzheimer's Disease Dementia
  • Alzheimer's Disease (AD)

Interventions

PROCEDURE

blood sampling

blood sampling for plasma biomarkers analyses

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giudo Maria Giuffrè · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2028-05-18
Completion
2028-05-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803055 on ClinicalTrials.gov