An interventional study of Digital solution for the prediction of the biological mechanisms of Alzheimer's disease through the analysis of risk factors in Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Screening
Population ageing is one of the main factors responsible for the global increase in the prevalence of dementia. Recent evidence suggests that modifiable risk factors, such as cardiovascular disease and lifestyle, may increase the risk of developing dementia and contribute to its progression. Furthermore, the use of non-invasive plasma biomarkers enables the identification of individuals with neurodegenerative diseases, even in the prodromal stage. However, the relationship between the cumulative burden of risk factors and plasma biomarkers is still poorly understood.
The main objective of this study is to identify and estimate the risk associated with modifiable and non-modifiable predictors (risk factors) linked to the development of Alzheimer's disease (AD) and non-AD dementia, as well as biological alterations consistent with AD or non-AD, through the development of a predictive tool based on Artificial Intelligence algorithms (Machine Learning model). The study also aims to provide a range of technological tools (an app for active patient monitoring and a web platform for clinicians) that could improve risk stratification and the personalisation of care pathways.
The study is divided into two different phases. Firstly, a retrospective phase is conducted in order to construct a predictive model for the risk of dementia and biological alterations consistent with AD. Secondly, a prospective phase is performed for the validation of the predictive model.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 240 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Digital solution for the prediction of the biological mechanisms of Alzheimer's disease through the analysis of risk factors
The intervention consists of a mobile application ("app") for risk monitoring with gamified patient engagement, which is design to support remote health monitoring and participant adherence to the study. Participants will enter informative clinical variables every 3 months, including weight, height, age, systolic/diastolic blood pressure, and blood glucose levels. The app generates a qualitative risk assessment (low/medium/high) based on entered data, intended as a clinical monitoring support tool for the participating sites and not as a diagnostic tool that replaces medical evaluation and/or clinical judgment. Unlike standard data collection apps, the intervention provides continuous engagement incentives in the form of visual feedback and motivational messaging.
Also known as: App for active patient monitoring
Conversion rate to dementia
Risk score that assesses the individual risk associated with predictors linked to (i) the development of AD and non-AD dementia, and (ii) biological biological changes consistent with AD or non-AD pathology.
Time frame: From enrollment to 3-6 months after enrollment
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IRCCS Centro San Giovanni di Dio Fatebenefratelli