Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAl)
23 luglio 2026 aggiornato da: Prof. Barbara Borroni, IRCCS Centro San Giovanni di Dio Fatebenefratelli
Development of Digital Solutions for the Prediction of the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAI)
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.
Panoramica dello studio
Stato
Reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
240
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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BS
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Brescia, BS, Italia, 25123
- Reclutamento
- ASST Spedali Civili di Brescia
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Contatto:
- Alessandro Padovani, MD
- Numero di telefono: +39 0303995632
- Email: alessandro.padovani@unibs.it
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Contatto:
- Luisa Alessandrini
- Numero di telefono: +39 0303996968
- Email: grant.office@asst-spedalicivili.it
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Brescia, BS, Italia, 25125
- Reclutamento
- IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
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Investigatore principale:
- Barbara Borroni, MD
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Contatto:
- Barbara Borroni, MD
- Numero di telefono: +39 0303501213
- Email: bborroni@fatebenefratelli.eu
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Subjects with MCI or SCD
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Conversion rate to dementia
Lasso di tempo: From enrollment to 3-6 months after enrollment
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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.
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From enrollment to 3-6 months after enrollment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
24 giugno 2026
Completamento primario (Stimato)
15 novembre 2026
Completamento dello studio (Stimato)
15 novembre 2026
Date di iscrizione allo studio
Primo inviato
23 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 luglio 2026
Primo Inserito (Effettivo)
28 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PrevAl
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .