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Biomarkers for Monitoring Dementia Progression

Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06855368
Acronym
ADvance
Enrollment
300
Registered
2025-03-03
Start date
2023-05-18
Completion date
2025-12-31
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

EEG, functional connectivity, neuroinflammation, nanoparticles

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.

Interventions

None listed

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* mild AD and patients with mild cognitive impairment (MCI).

Exclusion criteria

* major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness * any medical or drug-related condition affecting cognitive or mood status * history or current alcohol/illicit drug abuse.

Design outcomes

Primary

MeasureTime frameDescription
Identification of Disease-Associated Phenotypes in MCI and ADthrough study completion, an average of 1 year
Identification of Disease-Associated Early Interventions in MCI and ADthrough study completion, an average of 1 year
Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversionthrough study completion, an average of 1 yearEEG power spectral density
Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammationthrough study completion, an average of 1 year
Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammationthrough study completion, an average of 1 year
Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophagesthrough study completion, an average of 1 year
Assessment of Activated Leukosomes in Glial Cellsthrough study completion, an average of 1 year

Countries

Italy

Contacts

Primary ContactLucia Gatta, PhD
lucia.gatta@sanraffaele.it+390652253440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026