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Life sciences · Observational Study
ClinicalTrials.gov · November 4, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06855368). This is a study registration, not published results. Lead sponsor: IRCCS San Raffaele Roma. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 300 participants (ACTUAL). Conditions: Alzheimer Disease. Primary outcome measures: Identification of Disease-Associated Phenotypes in MCI and AD , through study completion, an average of 1 year; Identification of Disease-Associated Early Interventions in MCI and AD , through study completion, an average of 1 year; Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion , through study completion, an average of 1 year; Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation , through study completion, an average of 1 year; Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation , through study completion, an average of 1 year; Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages , through study completion, an average of 1 year; Assessment of Activated Leukosomes in Glial Cells , through study completion, an average of 1 year. Brief summary: The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype.