[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584912":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HellenCare","EXPERIMENTAL",null,[13],"Dietary Supplement: HellenCare",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","2 g, twice daily, to be taken on an empty stomach.",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100584912","efficacy-of-hellencare-in-early-stage-alzheimers-disease-100584912",false,"NCT06895525","Efficacy of HellenCare in Early-Stage Alzheimer's Disease","The HEART Study: A Randomized, Double-Blind, Parallel Placebo-Controlled Trial on the Efficacy of HellenCare in Early-Stage Alzheimer's Disease","Inclusion Criteria:\n\n* Participants aged 50 to 85 years\n* Clinically diagnosed for the first time with probable Alzheimer's disease dementia (AD dementia) or AD-related mild cognitive impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria.\n* MMSE (Mini-Mental State Examination): Score between 22 and 30.\n* CDR (Clinical Dementia Rating): Total score of 0.5 or 1. Memory domain score on CDR: ≥0.5.\n* Able to comply with study procedures and attend scheduled visits.\n* Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Presence of other dementia-causing conditions (e.g., vascular dementia, Lewy body dementia, etc)\n* Severe neurological comorbidities (e.g., history of seizures, cerebral infarction, intracerebral hemorrhage, traumatic brain injury, brain tumors, etc.)\n* Presence of severe anxiety, depression, schizophrenia, bipolar disorder, or other psychotic disorders requiring active treatment.\n* History of alcohol or drug dependence within the past 1 year.\n* Allergies to study dietary supplement.\n* Use of anti-dementia medications ( e.g., donepezil, galantamine, memantine, etc).","ALL","50 Years","85 Years",{"count":39,"type":40},60,"ESTIMATED","INTERVENTIONAL",[43],"NA","The goal of this clinical trial is to evaluate whether HellenCare, a multicomponent nutraceutical, improves cognitive and functional outcomes in patients with early-stage Alzheimer's disease (AD). The investigators will compare changes in outcomes between the HellenCare group and the placebo group to determine if the intervention is effective and safe.",[46],"Alzheimer's Disease Dementia","NOT_YET_RECRUITING","2025-04-06",{"date":50,"type":51},"2025-04-08","ACTUAL",{"date":53,"type":40},"2025-04-15",{"date":55,"type":40},"2025-12-31",{"name":5,"class":6}]