[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521343":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":35,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"DLB patients",null,"Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017",[13],"Diagnostic Test: EEG",{"label":15,"type":10,"description":16,"interventionNames":17},"AD patients","Alzheimer's disease according to McKhann et al., 2011 criteria including CSF biomarkers (an abnormal level of beta-amyloid 1-42 protein \\[Ab42\\] or a pathological Ab42\u002FAb40 ratio and an abnormal level of phosphorylated tau \\[p-tau\\])",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control","Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","EEG","32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap",[15,19,9],[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Claire PAQUET, MDPhD","CONTACT","0140054313","33","claire.paquet@aphp.fr",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centre de neurologie Cognitive","RECRUITING","Paris","France","75010","FR",{"type":44,"coordinates":45},"Point",[46,47],2.3488,48.85341,{"lat":47,"lon":46},[50],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":55,"class":56},"Association des Aidants et Malades à Corps de Lewy (A2MCL)","UNKNOWN","100521343","diagnostic-evaluation-of-dementia-with-lewy-bodies-using-a-multimodal-approach-100521343",false,"NCT06068361","Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach","Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers","EEG-EDELY","Inclusion Criteria for DLB ant AD patients:\n\n* Neuropsychological assessment possible (good level in French language, absence of visual\u002Fauditory deficit limiting the cognitive assessment)\n* Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017 or probable AD defined according to McKhann 2011 criteria including CSF biomarkers (an abnormal level of beta-amyloid 1-42 protein \\[Ab42\\] or a pathological Ab42\u002FAb40 ratio and an abnormal level of phosphorylated tau \\[p-tau\\])\n\nInclusion Criteria for control patients:\n\n* Neuropsychological assessment possible (good level in French language, absence of visual\u002Fauditory deficit limiting the cognitive assessment)\n* MMSE (Mini-mental State Examination) greater than or equal to 28, normal MemScreen test results, normal brain MRI and normal neurological examination\n\nExclusion Criteria (for all) :\n\n* Contraindication to MRI\n* Other neurological or psychiatric or toxic\u002Fiatrogenic disorders that may account for the cognitive impairment or for EEG abnormalities\n* Any unstable medical pathology and\u002For that may account for the cognitive impairment","ALL","55 Years","85 Years",{"count":69,"type":70},130,"ESTIMATED","OBSERVATIONAL","Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's disease (AD). Its variable clinical expression makes diagnosis difficult. To date, there is no validated DLB diagnostic biomarker, despite several biomarkers in development (EEG, MRI, biology).\n\nStudies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning.\n\nThe aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB (EEG, MRI, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.",[74,75,76],"Lewy Bodies Disease","Alzheimer Disease","Cognitive Impairment",[25,78,79],"MRI","Plasma biomarkers","2025-03-24",{"date":82,"type":83},"2025-03-27","ACTUAL",{"date":85,"type":83},"2024-09-11",{"date":87,"type":70},"2027-09",{"name":5,"class":6},1]