Longitudinal profiling of plasma-derived glial extracellular vesicles in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study longitudinally profiles plasma-derived glial extracellular vesicles (GDEVs) and neuroinflammation biomarkers across the Alzheimer’s disease continuum, from subjective cognitive decline to Alzheimer’s dementia. It also investigates how GDEV cargo relates to established biomarkers of amyloidopathy, tauopathy, and neurodegeneration, as well as cognitive and clinical progression. An innovative translational component exposes healthy human iPSC-derived neurons to disease-stage GDEVs to assess potential neurotoxic or priming effects. The study aims to identify early inflammatory signatures and develop non-invasive blood-based biomarkers to support diagnosis, prognosis, and disease monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For Ctrl: Individuals with no subjective or objective cognitive complaints, normal performance on standardized neuropsychological assessments, and normal AD biomarkers.
* For SCD-AD: Individuals reporting persistent self-perceived cognitive decline in the absence of objective cognitive impairment on standardized neuropsychological assessments and with preserved functional independence in activities of daily life, with abnormal AD biomarkers
* For MCI-AD: Individuals showing evidence of persistent cognitive decline, either self-reported or observed by an informant, with objective cognitive impairment on standardized neuropsychological assessments and with preserved independence in daily activities, with abnormal AD biomarkers
* For Dem-AD: Individuals with substantial progressive cognitive impairment affecting multiple domains and/or associated neuropsychiatric symptoms, confirmed by objective cognitive impairment on standardized neuropsychological assessments and a clear functional decline impacting independence, abnormal AD biomarkers
* For all subjects: Informed consent form signed by subject or caregiver

Exclusion Criteria:

* Exclusion criteria will be age \<55 or \>80 years, lack of a reliable study partner, previous or concomitant neurological diseases, major psychiatric disorders, medical conditions potentially able to interfere with cognitive functions, previous participation in experimental studies with amyloid targeting agents, significant systemic inflammatory diseases or use of immunosuppressive medication.

Where it's running

• Fondazione Policlinico Agostino Gemelli IRCCS
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Giudo Maria Giuffrè — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Guido Maria Giuffrè, PhD
• Email: guidomaria.giuffre@policlinicogemelli.it
• Phone: +390630157936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.