Clinical trial NCT06855368: Biomarkers for Monitoring Dementia Progression
Official title: Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Keywords: EEG
functional connectivity
neuroinflammation
nanoparticles
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 AD and 100 MCI individuals from the dementia clinical centres of North Sardinia and local sections of patients¿ associations and 100 HC will be recruited for the study. To investigate past/present health status and medications, baseline medical screening will be performed by general clinical and anthropometric examinations

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of Disease-Associated Phenotypes in MCI and AD
timeFrame: through study completion, an average of 1 year
measure: Identification of Disease-Associated Early Interventions in MCI and AD
timeFrame: through study completion, an average of 1 year
measure: Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion
timeFrame: through study completion, an average of 1 year
measure: Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation
timeFrame: through study completion, an average of 1 year
measure: Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation
timeFrame: through study completion, an average of 1 year
measure: Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages
timeFrame: through study completion, an average of 1 year
measure: Assessment of Activated Leukosomes in Glial Cells
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele
city: Sassari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Sassari
Study officials:
References: