Biomarkers for Monitoring Dementia Progression
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma
About this trial
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
This trial does not accept healthy volunteersQualifiers
mild AD and patients with mild cognitive impairment (MCI).
Disqualifiers
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.
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: AD
Group B: MCI
Group C: HC
Trial outcomes
Primary outcomes
1
Identification of Disease-Associated Phenotypes in MCI and AD
Time frame
through study completion, an average of 1 year2
Identification of Disease-Associated Early Interventions in MCI and AD
Time frame
through study completion, an average of 1 year3
Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion
EEG power spectral density
Time frame
through study completion, an average of 1 year4
Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov