Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAl)
23 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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BS
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Brescia, BS, Italia, 25123
- Reclutamiento
- ASST Spedali Civili di Brescia
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Contacto:
- Alessandro Padovani, MD
- Número de teléfono: +39 0303995632
- Correo electrónico: alessandro.padovani@unibs.it
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Contacto:
- Luisa Alessandrini
- Número de teléfono: +39 0303996968
- Correo electrónico: grant.office@asst-spedalicivili.it
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Brescia, BS, Italia, 25125
- Reclutamiento
- IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
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Investigador principal:
- Barbara Borroni, MD
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Contacto:
- Barbara Borroni, MD
- Número de teléfono: +39 0303501213
- Correo electrónico: bborroni@fatebenefratelli.eu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Conversion rate to dementia
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Mitchell AJ, Shiri-Feshki M. Rate of progression of mild cognitive impairment to dementia--meta-analysis of 41 robust inception cohort studies. Acta Psychiatr Scand. 2009 Apr;119(4):252-65. doi: 10.1111/j.1600-0447.2008.01326.x. Epub 2008 Feb 18.
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- McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
- Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.
- Biessels GJ, Despa F. Cognitive decline and dementia in diabetes mellitus: mechanisms and clinical implications. Nat Rev Endocrinol. 2018 Oct;14(10):591-604. doi: 10.1038/s41574-018-0048-7.
- Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/
- 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.
- Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
- Jessen F, Amariglio RE, Buckley RF, van der Flier WM, Han Y, Molinuevo JL, Rabin L, Rentz DM, Rodriguez-Gomez O, Saykin AJ, Sikkes SAM, Smart CM, Wolfsgruber S, Wagner M. The characterisation of subjective cognitive decline. Lancet Neurol. 2020 Mar;19(3):271-278. doi: 10.1016/S1474-4422(19)30368-0. Epub 2020 Jan 17.
- Jack CR Jr, Andrews JS, Beach TG, Buracchio T, Dunn B, Graf A, Hansson O, Ho C, Jagust W, McDade E, Molinuevo JL, Okonkwo OC, Pani L, Rafii MS, Scheltens P, Siemers E, Snyder HM, Sperling R, Teunissen CE, Carrillo MC. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169. doi: 10.1002/alz.13859. Epub 2024 Jun 27.
- Redolfi A, Manset D, Barkhof F, Wahlund LO, Glatard T, Mangin JF, Frisoni GB; neuGRID Consortium, for the Alzheimer's Disease Neuroimaging Initiative. Head-to-head comparison of two popular cortical thickness extraction algorithms: a cross-sectional and longitudinal study. PLoS One. 2015 Mar 17;10(3):e0117692. doi: 10.1371/journal.pone.0117692. eCollection 2015.
- Martinez-Dubarbie F, Guerra-Ruiz A, Lopez-Garcia S, Lage C, Fernandez-Matarrubia M, Infante J, Pozueta-Cantudo A, Garcia-Martinez M, Corrales-Pardo A, Bravo M, Lopez-Hoyos M, Irure-Ventura J, Valeriano-Lorenzo E, Garcia-Unzueta MT, Sanchez-Juan P, Rodriguez-Rodriguez E. Diagnostic Accuracy of Plasma p-tau217 for Detecting Pathological Cerebrospinal Fluid Changes in Cognitively Unimpaired Subjects Using the Lumipulse Platform. J Prev Alzheimers Dis. 2024;11(6):1581-1591. doi: 10.14283/jpad.2024.152.
- Sathyan A, Weinberg AI, Cohen K. Interpretable AI for bio-medical applications. Complex Eng Syst. 2022 Dec;2(4):18. doi: 10.20517/ces.2022.41. Epub 2022 Dec 28.
- Padovani A, Galli A, Bazzoli E, Tolassi C, Caratozzolo S, Gumina B, Benussi A, Libri I, Outeiro TF, Pilotto A. The role of insulin resistance and APOE genotype on blood-brain barrier integrity in Alzheimer's disease. Alzheimers Dement. 2025 Feb;21(2):e14556. doi: 10.1002/alz.14556.
- McKeith IG, Ferman TJ, Thomas AJ, Blanc F, Boeve BF, Fujishiro H, Kantarci K, Muscio C, O'Brien JT, Postuma RB, Aarsland D, Ballard C, Bonanni L, Donaghy P, Emre M, Galvin JE, Galasko D, Goldman JG, Gomperts SN, Honig LS, Ikeda M, Leverenz JB, Lewis SJG, Marder KS, Masellis M, Salmon DP, Taylor JP, Tsuang DW, Walker Z, Tiraboschi P; prodromal DLB Diagnostic Study Group. Research criteria for the diagnosis of prodromal dementia with Lewy bodies. Neurology. 2020 Apr 28;94(17):743-755. doi: 10.1212/WNL.0000000000009323. Epub 2020 Apr 2.
- Hooper C, Coley N, Delrieu J, Guyonnet S. Lifestyle factors and plasma biomarkers of Alzheimer's disease: A narrative review. J Prev Alzheimers Dis. 2025 Jun;12(6):100130. doi: 10.1016/j.tjpad.2025.100130. Epub 2025 Mar 12.
- Hayden KM, Mielke MM, Evans JK, Neiberg R, Molina-Henry D, Culkin M, Marcovina S, Johnson KC, Carmichael OT, Rapp SR, Sachs BC, Ding J, Shappell H, Wagenknecht L, Luchsinger JA, Espeland MA. Association between Modifiable Risk Factors and Levels of Blood-Based Biomarkers of Alzheimer's and Related Dementias in the Look AHEAD Cohort. JAR Life. 2024 Jan 5;13:1-21. doi: 10.14283/jarlife.2024.1. eCollection 2024.
- Altomare D, Stampacchia S, Ribaldi F, Tomczyk S, Chevalier C, Poulain G, Asadi S, Bancila B, Marizzoni M, Martins M, Lathuiliere A, Scheffler M, Ashton NJ, Zetterberg H, Blennow K, Kern I, Frias M, Garibotto V, Frisoni GB. Plasma biomarkers for Alzheimer's disease: a field-test in a memory clinic. J Neurol Neurosurg Psychiatry. 2023 Jun;94(6):420-427. doi: 10.1136/jnnp-2022-330619. Epub 2023 Apr 3.
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- Rasmussen Eid H, Rosness TA, Bosnes O, Salvesen O, Knutli M, Stordal E. Smoking and Obesity as Risk Factors in Frontotemporal Dementia and Alzheimer's Disease: The HUNT Study. Dement Geriatr Cogn Dis Extra. 2019 Jan 9;9(1):1-10. doi: 10.1159/000495607. eCollection 2019 Jan-Apr.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de junio de 2026
Finalización primaria (Estimado)
15 de noviembre de 2026
Finalización del estudio (Estimado)
15 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2026
Publicado por primera vez (Actual)
28 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PrevAl
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .