[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lewy-bodies-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lewy-bodies-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100643231","vocale-lbd-online-peer-support-for-caregivers-of-people-with-lewy-body-dementia-100643231",false,"NCT07637097","VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia","Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.","VOCALE LBD","Inclusion Criteria:\n\n* Current family member or informal (unpaid) caregiver of a person with a confirmed diagnosis of Lewy Body Dementia (LBD) or LBD mixed pathology\n* Experiences depressive symptoms as defined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)\n* Able to read, write, and speak English\n* Has access to a device (computer, tablet, or smartphone) that can connect to the internet and be used for videoconferencing or phone calls, OR is interested in using a loaner device\n\nExclusion Criteria:\n\n* Active suicidal ideation as indicated by endorsement of PHQ-9 Item 9 (thoughts that you would be better off dead, or thoughts of hurting yourself)\n* Paid or professional caregiver (must be unpaid family\u002Finformal caregiver)\n* Unable to read, write, or speak English","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study tests whether a tailored, fully asynchronous online group intervention (VOCALE LBD) reduces depression in family caregivers of people with Lewy Body Dementia (LBD), compared to standard educational materials. LBD is the second most common form of degenerative dementia and causes distinct challenges, including visual hallucinations, REM sleep disorder, and severe motor symptoms, that are not addressed by generic caregiver interventions. Depression rates in LBD caregivers reach 40-50%, double the rate seen in Alzheimer's disease caregivers, yet no rigorous digital interventions exist specifically for this population. VOCALE LBD is a text-based, low-bandwidth platform (Discourse) that brings groups of 10-15 caregivers together in an 8-week moderated online community. Weekly topics address LBD-specific challenges (sleep problems, hallucinations, self-care) and problem-solving skills using the ADAPT method. A pilot study (n=54) showed strong effects on depressive symptoms (Cohen's d=0.54 at 1-month follow-up), near-perfect engagement, and high participant satisfaction. This RCT (N=220) will test efficacy, examine mechanisms of action (self-efficacy and problem-solving), and explore analytics approaches for pragmatic monitoring, laying groundwork for future implementation in clinics and community organizations.",[27,28,29,30],"Lewy Bodies Disease","Depression Disorder","Caregiver Burden","Caregivers",[32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Lewy body disease","LBD","Family caregivers","Caregiver Depression","Online Intervention","Asynchronous","Digital Health","Peer Support","Problem-solving therapy","VOCALE","Telehealth","Dementia caregiver","ADAPT method","Discourse Platform","NOT_YET_RECRUITING","2026-06-03",{"date":49,"type":50},"2026-06-09","ACTUAL",{"date":52,"type":21},"2026-12-01",{"date":54,"type":21},"2030-11-30",{"name":56,"class":57},"University of Washington","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":58},"100521343","diagnostic-evaluation-of-dementia-with-lewy-bodies-using-a-multimodal-approach-100521343","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","55 Years","85 Years",{"count":70,"type":21},130,"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.",[27,74,75],"Alzheimer Disease","Cognitive Impairment",[77,78,79],"EEG","MRI","Plasma biomarkers","RECRUITING","2025-03-24",{"date":83,"type":50},"2025-03-27",{"date":85,"type":50},"2024-09-11",{"date":87,"type":21},"2027-09",{"name":89,"class":57},"Assistance Publique - Hôpitaux de Paris"]