Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Subjective Cognitive Decline (SCD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Spedali Civili di Brescia, Brescia, BS, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female subjects aged more than 18 years at the time of signing the informed consent form;
Subjects with MCI or SCD who, at the time of their first visit, did not have a clinical diagnosis of dementia (MMSE ≥ 24);
Smartphone user.

Exclusion criteria

Age younger than that stated in the inclusion criterion;
Inability to understand.

Treatment and study plan

Digital solution for the prediction of the biological mechanisms of Alzheimer's disease through the analysis of risk factors

Device

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.

Other names: App for active patient monitoring

Primary outcomes

Conversion rate to dementia

Time frame: From enrollment to 3-6 months after enrollment

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.

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Collaborators

Asst Degli Spedali Civili Di Brescia

Registry information

Official study title

Development of Digital Solutions for the Prediction of the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAI)

Acronym: PrevAl

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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