{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T16:49:03Z","timestamp":1793638143096,"version":"4.5.1"},"reference-count":38,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Union-Next Generation EU-\u201cPNRR M6C2- Investimento 2.1 Valorizzazione e potenziamento della ricerca biomedica del SSN\u201d","award":["PNRRMAD-2022-12375822"],"award-info":[{"award-number":["PNRRMAD-2022-12375822"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Geriatrics"],"abstract":"<jats:p>Background\/Objectives: At the international level, harmonized networks of dementia clinical studies are available, but Italian participation remains limited. This systematic review aims to define harmonization rules to facilitate the inclusion of Italian clinical studies in existing networks and to propose standardized data collection methods to enable comparison of the study results. Methods: A systematic review was conducted (January 2019\u2013December 2024) to identify Italian clinical studies evaluating Alzheimer\u2019s disease and other dementias as outcomes. Eight modifiable risk factors were extracted: BMI, arterial hypertension, diabetes, dietary patterns, alcohol consumption, smoking habits, depressive symptomatology, and physical activity. WHO definitions and internationally accepted criteria were used as reference standards. Variable harmonization potential was assessed using the DataSHaPER methodology and classified as complete, partial, or impossible, considering information loss across studies. Results: Of 365 records identified, 18 studies met the inclusion criteria. Obesity assessed via BMI showed the highest harmonization potential (44% complete, 33% partial), along with dietary habits measured by food frequency questionnaires (44% complete). Diabetes and physical inactivity followed (33% complete), assessed through fasting glucose or pharmacological treatment and the IPAQ, respectively. Smoking habits classified as current, former, or never smokers were reported in 28% of studies. Depression (assessed by GDS or CES-D) and hypertension (blood pressure measurement or antihypertensive treatment) showed complete harmonization in only 22% of studies. Conclusions: Italian studies show substantial limitations in the harmonization of modifiable risk factor data for Alzheimer\u2019s disease, mainly due to heterogeneous and non-standardized data collection methods, highlighting the need for uniform research protocols.<\/jats:p>","DOI":"10.3390\/geriatrics11020038","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T16:34:08Z","timestamp":1774974848000},"page":"38","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The Need for Standardized Data Collection to Improve Harmonization and Pooling of Information About Modifiable Risk Factors for Alzheimer\u2019s Diseases in Italian Clinical Studies: A Systematic Review"],"prefix":"10.3390","volume":"11","author":[{"given":"Patrizio","family":"Allegra","sequence":"first","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties\u2014PROMISE, University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4226-0714","authenticated-orcid":false,"given":"Manuela","family":"Lodico","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties\u2014PROMISE, University of Palermo, 90127 Palermo, Italy"},{"name":"Department of Diagnostic, Interventional and Stroke Radiology, UOC Neurology, AOUP \u201cP. Giaccone\u201d, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Migliazzo","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties\u2014PROMISE, University of Palermo, 90127 Palermo, Italy"},{"name":"Department of Diagnostic, Interventional and Stroke Radiology, UOC Neurology, AOUP \u201cP. Giaccone\u201d, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Tarantino","sequence":"additional","affiliation":[{"name":"Department of Diagnostic, Interventional and Stroke Radiology, UOC Neurology, AOUP \u201cP. Giaccone\u201d, 90127 Palermo, Italy"},{"name":"Department of Biomedicine, Neuroscience and Advanced Diagnostics (BIND), University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3410-2067","authenticated-orcid":false,"given":"Tommaso","family":"Piccoli","sequence":"additional","affiliation":[{"name":"Department of Diagnostic, Interventional and Stroke Radiology, UOC Neurology, AOUP \u201cP. Giaccone\u201d, 90127 Palermo, Italy"},{"name":"Department of Biomedicine, Neuroscience and Advanced Diagnostics (BIND), University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2817-3758","authenticated-orcid":false,"given":"Nicola","family":"Vanacore","sequence":"additional","affiliation":[{"name":"National Center for Disease Prevention and Health Promotion, Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3756-4323","authenticated-orcid":false,"given":"Giuseppe","family":"Salemi","sequence":"additional","affiliation":[{"name":"Department of Diagnostic, Interventional and Stroke Radiology, UOC Neurology, AOUP \u201cP. Giaccone\u201d, 90127 Palermo, Italy"},{"name":"Department of Biomedicine, Neuroscience and Advanced Diagnostics (BIND), University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7974-3963","authenticated-orcid":false,"given":"Laura","family":"Maniscalco","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties\u2014PROMISE, University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2466-937X","authenticated-orcid":false,"given":"Domenica","family":"Matranga","sequence":"additional","affiliation":[{"name":"Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties\u2014PROMISE, University of Palermo, 90127 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"572","DOI":"10.1016\/S0140-6736(24)01296-0","article-title":"Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission","volume":"404","author":"Livingston","year":"2024","journal-title":"Lancet"},{"key":"ref_2","unstructured":"Georges, J., Miller, O., and Bintener, C. (2025, July 30). Estimating the Prevalence of Dementia in Europe. Available online: http:\/\/rgdoi.net\/10.13140\/RG.2.2.16880.81923."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"564","DOI":"10.1038\/s41597-023-02461-z","article-title":"A Dementia mortality rates dataset in Italy (2012\u20132019)","volume":"10","author":"Fania","year":"2023","journal-title":"Sci. Data"},{"key":"ref_4","first-page":"S4","article-title":"Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group","volume":"54","author":"Lobo","year":"2000","journal-title":"Neurology"},{"key":"ref_5","first-page":"P111","article-title":"The Global Alzheimer\u2019s Association Interactive Network","volume":"11","author":"Toga","year":"2015","journal-title":"Alzheimer\u2032s Dement."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"31","DOI":"10.3233\/JAD-210525","article-title":"Connecting Cohorts to Diminish Alzheimer\u2019s Disease (CONCORD-AD): A Report of an International Research Collaboration Network","volume":"85","author":"Pavlik","year":"2022","journal-title":"J. Alzheimer\u2032s Dis."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"941","DOI":"10.3233\/JAD-132666","article-title":"The Italian Alzheimer\u2019s Disease Neuroimaging Initiative (I-ADNI): Validation of structural MR imaging","volume":"40","author":"Cavedo","year":"2014","journal-title":"J. Alzheimer\u2019s Dis."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/j.jclinepi.2021.02.003","article-title":"Updating guidance for reporting systematic reviews: Development of the PRISMA 2020 statement","volume":"134","author":"Page","year":"2021","journal-title":"J. Clin. Epidemiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1186\/s13643-016-0384-4","article-title":"Rayyan-a web and mobile app for systematic reviews","volume":"5","author":"Ouzzani","year":"2016","journal-title":"Syst. Rev."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1383","DOI":"10.1093\/ije\/dyq139","article-title":"Quality, quantity and harmony: The DataSHaPER approach to integrating data across bioclinical studies","volume":"39","author":"Fortier","year":"2010","journal-title":"Int. J. Epidemiol."},{"key":"ref_11","first-page":"1033","article-title":"Toward Rigorous Data Harmonization in Cancer Epidemiology Research: One Approach","volume":"182","author":"Rolland","year":"2015","journal-title":"Am. J. Epidemiol."},{"key":"ref_12","unstructured":"World Health Organization (2017). Guideline: Assessing and Managing Children at Primary Health-Care Facilities to Prevent Overweight and Obesity in the Context of the Double Burden of Malnutrition, World Health Organization. Available online: https:\/\/iris.who.int\/handle\/10665\/259133."},{"key":"ref_13","unstructured":"World Health Organization (2024). WHO Clinical Treatment Guideline for Tobacco Cessation in Adults, World Health Organization."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"382","DOI":"10.1111\/psyg.12827","article-title":"Validation of the five-item version of the Geriatric Depression Scale (GDS-5) in a Turkish elderly population","volume":"22","author":"Gokcekuyu","year":"2022","journal-title":"Psychogeriatrics"},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"El-Ammari, A., El Malki, H., Moutawakkil, S.G., El Hilaly, J., El Houari, F., El Gnaoui, S., Ragala, M.E.A., El Rhazi, K., and Zarrouq, B. (2023). Validation of the Center for Epidemiologic Studies Depression Scale (CES-D) in a Moroccan sample with substance use disorder. BMC Psychiatry, 23.","DOI":"10.1186\/s12888-023-05245-2"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1381","DOI":"10.1249\/01.MSS.0000078924.61453.FB","article-title":"International physical activity questionnaire: 12-country reliability and validity","volume":"35","author":"Craig","year":"2003","journal-title":"Med. Sci. Sports Exerc."},{"key":"ref_17","unstructured":"World Health Organization, and International Diabetes Federation (2025, July 30). Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycaemia: Report of a WHO\/IDF Consultation. Available online: https:\/\/iris.who.int\/handle\/10665\/43588."},{"key":"ref_18","unstructured":"World Health Organization (2021). Guideline for the Pharmacological Treatment of Hypertension in Adults, World Health Organization. [1st ed.]."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Cardamone, E., Iacoponi, F., Fiori, F., Marinoni, M., Agrimi, U., Silano, M., and Parpinel, M. (2024). The Development of a Food Frequency Questionnaire for the Assessment of Ultra-Processed Food Consumption in the Italian Adult Population: Protocol for a Validity and Reproducibility Study. Nutrients, 16.","DOI":"10.3390\/nu16223896"},{"key":"ref_20","unstructured":"World Health Organization (2000). International Guide for Monitoring Alcohol Consumption and Related Harm, World Health Organization."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Giampieri, F., Godos, J., Caruso, G., Owczarek, M., Jurek, J., Castellano, S., Ferri, R., Caraci, F., and Grosso, G. (2022). Dietary Phytoestrogen Intake and Cognitive Status in Southern Italian Older Adults. Biomolecules, 12.","DOI":"10.3390\/biom12060760"},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Mazzoli, R., Chiari, A., Vitolo, M., Garuti, C., Adani, G., Vinceti, G., Zamboni, G., Tondelli, M., Galli, C., and Costa, M. (2024). Atrial Fibrillation and Other Cardio-vascular Factors and the Risk of Dementia: An Italian Case-Control Study. Int. J. Environ. Res. Public Health, 21.","DOI":"10.3390\/ijerph21060688"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Currenti, W., Godos, J., Alanazi, A.M., Lanza, G., Ferri, R., Caraci, F., Grosso, G., Galvano, F., and Castellano, S. (2023). Dietary Fats and Cognitive Status in Italian Middle-Old Adults. Nutrients, 15.","DOI":"10.3390\/nu15061429"},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Currenti, W., Godos, J., Castellano, S., Caruso, G., Ferri, R., Caraci, F., Grosso, G., and Galvano, F. (2021). Association between Time Restricted Feeding and Cognitive Status in Older Italian Adults. Nutrients, 13.","DOI":"10.3390\/nu13010191"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1195","DOI":"10.1002\/acn3.51619","article-title":"Modifiable potential risk factors in familial and sporadic frontotemporal dementia","volume":"9","author":"Soppela","year":"2022","journal-title":"Ann. Clin. Transl. Neurol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"708","DOI":"10.14283\/jpad.2022.78","article-title":"Age, Sex, Hypertension and HDL-C Alter Serum BACE1 Activity in Cognitively Normal Subjects: Implications for Alzheimer\u2019s Disease","volume":"9","author":"Cervellati","year":"2022","journal-title":"J. Prev. Alzheimer\u2019s Dis."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"e472","DOI":"10.3399\/bjgp20X709589","article-title":"Systolic inter-arm blood pressure difference and risk of cognitive decline in older people: A cohort study","volume":"70","author":"Clark","year":"2020","journal-title":"Br. J. Gen. Pract."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1007\/s40520-024-02806-7","article-title":"Dysglycemia, gender, and cognitive performance in older persons living with mild cognitive impairment: Findings from a cross-sectional, population-based study","volume":"36","author":"Boccardi","year":"2024","journal-title":"Aging Clin. Exp. Res."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1871","DOI":"10.1016\/j.clnu.2018.07.010","article-title":"The outcomes of long term home enteral nutrition (HEN) in older patients with severe dementia","volume":"38","author":"Orlandoni","year":"2019","journal-title":"Clin. Nutr."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"4783","DOI":"10.1016\/j.clnu.2021.06.016","article-title":"The role of diet on the risk of dementia in the oldest old: The Monzino 80-plus population-based study","volume":"40","author":"Nicoli","year":"2021","journal-title":"Clin. Nutr."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Prinelli, F., Jesuthasan, N., Severgnini, M., Musicco, M., Adorni, F., Correa Leite, M.L., Crespi, C., and Bernini, S. (2020). Exploring the relationship between Nutrition, gUT microbiota, and BRain AgINg in community-dwelling seniors: The Italian NutBrain population-based cohort study protocol. BMC Geriatr., 20.","DOI":"10.1186\/s12877-020-01652-2"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1186\/s13195-020-00661-y","article-title":"Estimating the potential for dementia prevention through modifiable risk factors elimination in the real-world setting: A population-based study","volume":"12","author":"Rolandi","year":"2020","journal-title":"Alzheimer\u2019s Res. Ther."},{"key":"ref_33","doi-asserted-by":"crossref","unstructured":"Caff\u00f2, A.O., Spano, G., Tinella, L., Lopez, A., Ricciardi, E., Stasolla, F., and Bosco, A. (2022). The Prevalence of Amnestic and Non-Amnestic Mild Cognitive Impairment and Its Association with Different Lifestyle Factors in a South Italian Elderly Population. Int. J. Environ. Res. Public Health, 19.","DOI":"10.3390\/ijerph19053097"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2372","DOI":"10.1016\/j.clnu.2024.09.001","article-title":"Undernutrition, cognitive decline and dementia: The collaborative PROMED-COG pooled cohorts study","volume":"43","author":"Noale","year":"2024","journal-title":"Clin. Nutr."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"717","DOI":"10.3233\/JAD-190495","article-title":"The LIBRA Index in Relation to Cognitive Function, Functional Independence, and Psycho-Behavioral Symptoms in a Sample of Non-Institutionalized Seniors at Risk of Dementia","volume":"72","author":"Franchini","year":"2019","journal-title":"J. Alzheimer\u2019s Dis."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"100040","DOI":"10.1016\/j.jnha.2024.100040","article-title":"Investigating the individual and joint effects of socioeconomic status and lifestyle factors on mild cognitive impairment in older Italians living independently in the com-munity: Results from the NutBrain study","volume":"28","author":"Bernini","year":"2024","journal-title":"J. Nutr. Health Aging"},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Filippini, T., Adani, G., Malavolti, M., Garuti, C., Cilloni, S., Vinceti, G., Zamboni, G., Tondelli, M., Galli, C., and Costa, M. (2020). Dietary Habits and Risk of Early-Onset Dementia in an Italian Case-Control Study. Nutrients, 12.","DOI":"10.3390\/nu12123682"},{"key":"ref_38","doi-asserted-by":"crossref","unstructured":"Adani, G., Filippini, T., Garuti, C., Malavolti, M., Vinceti, G., Zamboni, G., Tondelli, M., Galli, C., Costa, M., and Vinceti, M. (2020). Environmental Risk Factors for Early-Onset Alzheimer\u2019s Dementia and Frontotemporal Dementia: A Case-Control Study in Northern Italy. Int. J. Environ. Res. Public Health, 17.","DOI":"10.3390\/ijerph17217941"}],"container-title":["Geriatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2308-3417\/11\/2\/38\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T16:56:24Z","timestamp":1774976184000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2308-3417\/11\/2\/38"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,31]]},"references-count":38,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,4]]}},"alternative-id":["geriatrics11020038"],"URL":"https:\/\/doi.org\/10.3390\/geriatrics11020038","relation":{},"ISSN":["2308-3417"],"issn-type":[{"value":"2308-3417","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,31]]}}}