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

NCT07803055 | Recruiting

• 1 other identifier: 27072
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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); Alzheimer's Disease Dementia; Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Keywords

Extracellular Vesicles; Neuroinflammation; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Longitudinal changes

  Longitudinal changes in plasma-derived GDEV cargo and neuroinflammation biomarkers across the Alzheimer's disease continuum

  24 months

• Disease-stage-specific molecular signatures

  Identification of disease-stage-specific GDEV molecular signatures associated with progression along the AD continuum

  24 months

Secondary Outcomes (4)

• Associations between biomarkers

  24 months

• Relationships with Clinical Measures

  24 months

• Predictive Value

  24 months

• Neurotoxic or priming effects

  24 months

Study Arms (1)

Single Arm

OTHER

single arm

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

blood sampling for plasma biomarkers analyses

Single Arm

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Neuroinflammatory Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giudo Maria Giuffrè

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Maria Giuffrè, PhD

CONTACT

+390630157936; guidomaria.giuffre@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: September 3, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 18, 2028
• Study Completion (Estimated): May 18, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)