Digital tools to predict Alzheimer's biology from risk factors
Official title: Development of Digital Solutions for the Prediction of the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAI)
Run by IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT07731191 · Data updated 2026-11-12
This study tests a digital, AI-based tool that analyzes modifiable and non-modifiable risk factors to see if it can predict biological changes linked to Alzheimer's disease in adults with MCI or SCD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 2 sites (Brescia, BS and 1 other locations) |
| Status | Recruiting |
| Started | June 24, 2026 |
| Main results expected | November 15, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07731191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with MCI or SCD, who use smartphones and have MMSE ≥ 24 at baseline.
✕Probably not a fit
Individuals without MCI or SCD, or those with established dementia at baseline, may not benefit from this tool.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will develop and test a machine learning model using risk-factor data and non-invasive plasma biomarkers to predict the biological mechanisms of Alzheimer's disease and other dementias. The project focuses on people with mild cognitive impairment or subjective cognitive decline, who are not yet diagnosed with dementia. The approach relies on digital health methods and smartphone-enabled data collection to identify patterns associated with disease biology. By linking risk profiles to biomarker signals, the study aims to create a predictive tool that could inform early interventions. The study is exploratory and will inform future validation in diverse populations.
Why it matters
Potential benefit: If successful, the tool could help identify individuals at higher risk of Alzheimer's-related changes early, enabling targeted monitoring or interventions.
How similar studies have gone: While digital and biomarker-based approaches have shown promise in other dementia studies, this exact predictive tool is exploratory and builds on early signals rather than proven results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ASST Spedali Civili di Brescia
Brescia, Bs, Italy Recruiting -
IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
Brescia, Bs, Italy Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Aging Brain Health Initiative in Fujian
This observational study will follow about 3,000 older adults in Fujian to see how Alzheimer's-related changes develop and to test new digital tests, biomarkers, and imaging tools for early diagnosis.
-
Online positive psychology program to support thinking and brain health in early memory changes
This study will test whether an online positive psychology program can improve thinking, brain function, and wellbeing in older adults with early memory problems (Subjective Cognitive Decline or Mild Cognitive Impairment).
-
Personalized digital training for cognitive fitness in people with mild cognitive impairment
This study tests whether a personalized home-based digital program (RICORDO) helps people aged 50 and older with mild cognitive impairment or subjective cognitive decline manage their health and daily life better than a paper-and-video education program.
-
NPC-1 (parthenolide and ipriflavone) for Alzheimer's blood biomarkers
This trial will test whether taking NPC-1 (a combination of parthenolide and ipriflavone) is safe, well tolerated, and changes blood tests linked to Alzheimer's in adults 55+ with subjective cognitive decline, mild cognitive impairment, or mild Alzheimer's who have biomarker evidence of disease.
-
InRAD international registry for Alzheimer's disease and related dementias
This project will collect routine medical information over time to see how Alzheimer's disease, mild cognitive impairment, and related dementias progress and how current treatments are tolerated in adults.
-
Accelerated deep TMS to boost memory and thinking in older adults with mild memory problems
We will test whether a short, intensive course of deep transcranial magnetic stimulation to the anterior cingulate plus online cognitive training can improve memory and thinking in people aged 55–85 with mild cognitive impairment or subjective memory decline.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.