protocolSection identificationModule nctId: NCT06321588, orgStudyIdInfo id: GR-2021-12373134, briefTitle: Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment, acronym: ADONIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Azienda Usl di Bologna, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to investigate the frequency and the possible pathogenic role of neuronal synaptic antibodies (NSAb) in patients with cognitive impairment (CI). The main questions it aims to answer are:1. the frequency and associated features of NSAb in patients with CI and the usefulness of a clinical score in improving autoimmune dementia (AID) diagnosis;2. the clinical significance of NSAb in patients with CI not fulfilling the autoimmune encephalitis (AE) criteria and serum NSAb (NSAb-pos-CI);3. the impact of blood-brain-barrier (BBB) dysfunction on their pathogenicity., conditionsModule conditions: Cognitive Impairment, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: frequency of antibodies against neuronal antigens, primaryOutcomes measure: frequency of antibodies against neuronal antigens, primaryOutcomes measure: creation of a score that predicts the presence of NSAb, secondaryOutcomes measure: changes of neurodegeneration biomarkers, secondaryOutcomes measure: changes of neurodegeneration biomarkers, secondaryOutcomes measure: changes of neuroanatomy, secondaryOutcomes measure: changes of neuroanatomy, secondaryOutcomes measure: changes of inflammatory biomarkers, secondaryOutcomes measure: changes of inflammatory biomarkers, secondaryOutcomes measure: changes of brain blood barrier biomarkers, secondaryOutcomes measure: changes of brain blood barrier biomarkers, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, status: RECRUITING, city: Bologna, zip: 40139, country: Italy, contacts name: Maria Pia Giannoccaro, Dr., role: CONTACT, phone: 0514966117, email: mariapia.giannoccaro@ausl.bologna.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milano, zip: 20095, country: Italy, contacts name: Federico Verde, Dr., role: CONTACT, phone: +3902619112247, email: f.verde@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, status: RECRUITING, city: Milano, zip: 20133, country: Italy, contacts name: Chiara Maria Giulia De Luca, Dr., role: CONTACT, phone: +390223942498, email: chiara.deluca@istituto-besta.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False