[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570006":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Casa di Cura IGEA","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Neurologically unimpaired participants",null,"i) Age ≥ 60 years; ii) Availability of an informant\u002Fcaregiver, able to judge their functional abilities; iii) Normal performance on the Mini Mental State Examination (Folstein et al. 1975; Foderaro et al., 2022).",{"label":13,"type":10,"description":14,"interventionNames":10},"Subjective Cognitive Decline (SCD)","i) Age ≥ 60 years; ii) Availability of an informant\u002Fcaregiver, able to judge their functional abilities.\n\niii) Conditions consistent with Subjective Cognitive Decline according to Jessen et al. (2014)",{"label":16,"type":10,"description":17,"interventionNames":10},"Mild Cognitive Impairment (MCI)","i) Age ≥ 60 years; ii) Availability of an informant\u002Fcaregiver, able to judge their functional abilities.\n\niii) Conditions consistent with Mild Cognitive Impairment according to Winblad et al. (2004)",{"label":19,"type":10,"description":20,"interventionNames":10},"Major Neurocognitive Disorder","i) Age ≥ 60 years; ii) Availability of an informant\u002Fcaregiver, able to judge their functional abilities iii) Conditions consistent with a Mild Major Neurocognitive Disorder according to DSM-5-TR (APA, 2022).",[22],{"name":23,"affiliation":24,"role":25},"Sabrina Guzzetti","Casa di Cura IGEA, Milan, Italy","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Sabrina Guzzetti, Psychologist","CONTACT","+390248593315","s.guzzetti@casadicurigea.it",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Laura Veronelli, PhD","+390264483704","laura.veronelli@unimib.it",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Casa di Cura Igea","RECRUITING","Milan","Michigan","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],12.59836,42.78235,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":10,"email":54},"Sabrina Guzzetti, PsyD","+3948593315","s.guzzetti@casadicuraigea.it",{"type":25,"investigatorFullName":23,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Psychologist, principal investigator","100570006","italian-adaptation-and-validation-of-functional-and-behavioural-scales-for-subjective-cognitive-decline-mild-cognitive-impairment-and-mild-dementia-100570006",false,"NCT06701630","Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.","Functional and Behavioural Scales Validation in Italian.","ITA-VALI-DEM","Inclusion Criteria:\n\n* Age ≥ 60 years;\n* Availability of an informant\u002Fcaregiver, able to judge their functional abilities.\n\nFor neurologically unimpaired elderly:\n\n\\- Normal performance on the Mini Mental State Examination (Folstein et al. 1975; Foderaro et al., 2022).\n\nFor clinical groups: Conditions consistent with:\n\n* Subjective Cognitive Decline (Jessen et al., 2014)\n* Mild Cognitive Impairment (Winblad et al., 2004)\n* Mild Major Neurocognitive Disorder according (DSM-5-TR, APA, 2022).\n\nExclusion Criteria:\n\n* Refusal or inability to sign informed consent;\n* For the clinical groups: other neurological or psychiatric conditions that may explain the presence of cognitive difficulties.",true,"ALL","60 Years",{"count":69,"type":70},390,"ESTIMATED","1 Day","OBSERVATIONAL","The first aim of the observational study is the translation, cross-cultural adaptation and validation of functional and behavioral scales used in the diagnosis of neurodegenerative diseases, for which a formal version in Italian is not available at present. In particular, the study includes the following functional and behavioral scales: the Katz's index (Basic Activities of Daily Living, BADL), the Lawton and Brody's scale (Instrumental Activities of Daily Living, IADL), the Everyday Cognition questionnaire (E-Cog), the Neuropsychiatric Inventory Questionnaire (NPI-Q) for assessing the Behavioral and Psychological Symptoms of Dementia. Furthermore, a modified Italian version of the Functional Activities Questionnaire (FAQ), which integrates and updates the content of the original items (e.g., addressing the use of technologies, M-FAQ) will be used in the validation study.\n\nThe second aim is to evaluate the psychometric properties of the M-FAQ, the ECog, and the NPI-Q in terms of reliability and validity.\n\nThe third aim is to apply a Receiver Operating Characteristic (ROC) curve analysis to identify cut-offs of IADL, M-FAQ and ECOG to discriminate between different clinical groups (i.e., neurologically unimpaired elderly; Subjective Cognitive Decline, SCD; Mild Cognitive Impairment, MCI; mild Alzheimer's Disease, AD).\n\nNeurologically unimpaired elderly participants (over 60 years old) and participants with SCD, MCI, mild AD, and their caregivers\u002Finformants will undergo: i) administration of the translated versions of the scales; ii) administration of a Cognitive Reserve questionnaire. For SCD, MCI and AD participants, data from the clinical neuropsychological evaluation will also be collected, while paper-and-pencil psychometric tests to assess global cognitive functioning (Mini Mental State Examination) and logical-abstract reasoning (Raven's Colored Matrices) will be administered to the neurologically unimpaired participants.",[75,13,16,19],"Neurologically Unimpaired Elderly Participants",[77,78,79,80,81,82,83],"BADL and IADL","FAQ scale","ECog","NPI-Q","Italian adaptation","Validation","Functional and behavioral scales","2025-02-11",{"date":86,"type":87},"2025-02-13","ACTUAL",{"date":89,"type":87},"2024-11-26",{"date":91,"type":70},"2026-11-30",{"name":5,"class":6},1]