Biomarkers for Monitoring Dementia Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Identification of Disease-Associated Phenotypes in MCI and AD [Time frame: through study completion, an average of 1 year]
- Identification of Disease-Associated Early Interventions in MCI and AD [Time frame: through study completion, an average of 1 year]
- Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion [Time frame: through study completion, an average of 1 year]
- Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation [Time frame: through study completion, an average of 1 year]
- Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation [Time frame: through study completion, an average of 1 year]
- Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages [Time frame: through study completion, an average of 1 year]
- Assessment of Activated Leukosomes in Glial Cells [Time frame: through study completion, an average of 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Italy · 2 centers
- IRCCS San Raffaele — Roma
- Azienda Ospedaliero-Universitaria di Sassari — Sassari
Identifiers
NCT: NCT06855368 · RP 22/25