Alzheimer's Disease Dementia / Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease / Subjective Cognitive Decline (SCD) · Interventional Study
ClinicalTrials.gov · September 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned longitudinal observational study registered on ClinicalTrials.gov with no results yet posted. The study will enroll 48 participants across three stages of the Alzheimer's disease spectrum to profile plasma glial extracellular vesicles (GDEVs) and neuroinflammatory biomarkers over 24 months and examine their neurotoxic effects in iPSC-derived neurons.
Interventional, Single Group, Open label, Diagnostic purpose. Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Alzheimer's Disease Dementia, Alzheimer's Disease (AD); age from 55 Years; to 80 Years; accepts healthy volunteers. Intervention: Single Arm. n = 48. 1 site: Italy.
This is a planned longitudinal observational study registered on ClinicalTrials.gov with no results yet posted. The study will enroll 48 participants across three stages of the Alzheimer's disease spectrum to profile plasma glial extracellular vesicles (GDEVs) and neuroinflammatory biomarkers over 24 months and examine their neurotoxic effects in iPSC-derived neurons.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a recruiting registry record with no reported results; it describes a planned longitudinal observational study of biomarkers across the Alzheimer's disease continuum.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07803055). This is a study registration, not published results. Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 48 participants (ESTIMATED). 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. Primary outcome measures: Longitudinal changes , 24 months; Disease-stage-specific molecular signatures , 24 months. 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.
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