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NCT07731191Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
23 Jul 2026
Start date
24 Jun 2026
Primary completion date
15 Nov 2026
Lead sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
NCT number
NCT07731191

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 24 Jun 2026 to the primary completion date, 15 Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age younger than that stated in the inclusion criterion;

Other

  • Inability to understand.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
ASST Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.