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

NCT07731191 | Recruiting

• 1 other identifier: PrevAl
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD)

Outcome Measures

Primary Outcomes (1)

• Conversion rate to dementia

  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.

  From enrollment to 3-6 months after enrollment

Study Arms (1)

Subjects with MCI or SCD

EXPERIMENTAL

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

Interventions

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.

Also known as: App for active patient monitoring

Subjects with MCI or SCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to understand.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Asst Degli Spedali Civili Di Brescia: collaborator

Study Sites (2)

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

RECRUITING

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli

Brescia, BS, 25125, Italy

RECRUITING

Related Publications (25)

• 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.

  PMID: 25781983 BACKGROUND

• 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.

  PMID: 19236314 BACKGROUND

• 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.

  PMID: 39559871 BACKGROUND

• 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.

  PMID: 37025127 BACKGROUND

• 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.

  PMID: 39992249 BACKGROUND

• 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.

  PMID: 31958406 BACKGROUND

• 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.

  PMID: 32241955 BACKGROUND

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 28592453 BACKGROUND

• 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.

  PMID: 21325651 BACKGROUND

• 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.

  PMID: 21810890 BACKGROUND

• McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

  PMID: 21514250 BACKGROUND

• 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.

  PMID: 38934362 BACKGROUND

• 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.

  PMID: 30022099 BACKGROUND

• 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.

  PMID: 40082178 BACKGROUND

• 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.

  PMID: 38204926 BACKGROUND

• 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.

  PMID: 37012066 BACKGROUND

• Ashton NJ, Janelidze S, Al Khleifat A, Leuzy A, van der Ende EL, Karikari TK, Benedet AL, Pascoal TA, Lleo A, Parnetti L, Galimberti D, Bonanni L, Pilotto A, Padovani A, Lycke J, Novakova L, Axelsson M, Velayudhan L, Rabinovici GD, Miller B, Pariante C, Nikkheslat N, Resnick SM, Thambisetty M, Scholl M, Fernandez-Eulate G, Gil-Bea FJ, Lopez de Munain A, Al-Chalabi A, Rosa-Neto P, Strydom A, Svenningsson P, Stomrud E, Santillo A, Aarsland D, van Swieten JC, Palmqvist S, Zetterberg H, Blennow K, Hye A, Hansson O. A multicentre validation study of the diagnostic value of plasma neurofilament light. Nat Commun. 2021 Jun 7;12(1):3400. doi: 10.1038/s41467-021-23620-z.

  PMID: 34099648 BACKGROUND

• 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.

  PMID: 30792733 BACKGROUND

• Borroni B, Alberici A, Agosti C, Premi E, Padovani A. Education plays a different role in Frontotemporal Dementia and Alzheimer's disease. Int J Geriatr Psychiatry. 2008 Aug;23(8):796-800. doi: 10.1002/gps.1974.

  PMID: 18172915 BACKGROUND

• Soppela H, Katisko K, Gadola Y, Kruger J, Hartikainen P, Alberici A, Benussi A, Koivisto A, Haapasalo A, Remes AM, Borroni B, Solje E. Modifiable potential risk factors in familial and sporadic frontotemporal dementia. Ann Clin Transl Neurol. 2022 Aug;9(8):1195-1205. doi: 10.1002/acn3.51619. Epub 2022 Jun 29.

  PMID: 35767471 BACKGROUND

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 BACKGROUND

• Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/

  PMID: 31219687 BACKGROUND

• 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.

  PMID: 39096926 BACKGROUND

• Feigin VL, Vos T, Nichols E, Owolabi MO, Carroll WM, Dichgans M, Deuschl G, Parmar P, Brainin M, Murray C. The global burden of neurological disorders: translating evidence into policy. Lancet Neurol. 2020 Mar;19(3):255-265. doi: 10.1016/S1474-4422(19)30411-9. Epub 2019 Dec 5.

  PMID: 31813850 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IT (2)