[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576297":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":70,"overallOfficials":53,"centralContacts":76,"locations":86,"responsibleParty":102,"collaborators":53,"id":104,"slug":53,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":53,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":53,"enrollmentInfo":112,"targetDuration":53,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":53,"overallStatus":89,"whyStopped":53,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Taipei Medical University WanFang Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Instrumental Activities of Daily Living (IADL)","e.g., K-IADL (Korean Instrumental Activities of Daily Living): range from 0 to 33; Higher scores = worse outcomes, lower scores = better independence.","Baseline, Week 8, Week 16",[14,17,19,22],{"measure":15,"description":16,"timeFrame":12},"The Montreal Cognitive Assessment (MoCA)","Range: 0 to 30; Higher scores indicate better cognitive function.",{"measure":18,"description":16,"timeFrame":12},"Mini-Mental State Examination score (MMSE)",{"measure":20,"description":21,"timeFrame":12},"Clinical Dementia Rating score (CDR)","Range: 0 to 3; Higher scores indicate greater severity of dementia.",{"measure":23,"description":24,"timeFrame":12},"Executive Function Performance Test score (EFPT)","Range: 0 to 100; Higher scores indicate worse executive functioning.",[26,29,32,35,38,41,44,47],{"measure":27,"description":28,"timeFrame":12},"Geriatric Depression Scale (GDS-15)","Range: 0 to 15; Higher scores indicate greater levels of depressive symptoms.",{"measure":30,"description":31,"timeFrame":12},"The Family Confusion Assessment Method (FAM-CAM)","Range: Scored as present or absent; Presence indicates delirium.",{"measure":33,"description":34,"timeFrame":12},"Activities of Daily Living (ADL) score","Higher scores indicate greater independence: e.g., Katz ADL--range from 0 to 6; Barthel Index--range from 0 to 100.",{"measure":36,"description":37,"timeFrame":12},"WAIS-III Digit span forward, backward, and sequencing","Range: Variable (raw scores depend on the total number of correct trials, typically ranging from 0 to \\~30, depending on individual performance).\n\nStandardized Scoring: Raw scores are converted to age-specific scaled scores, typically ranging from 1 to 19.\n\nInterpretation: Higher scores indicate better short-term memory, working memory, and cognitive processing capacity.",{"measure":39,"description":40,"timeFrame":12},"Frontal assessment battery (FAB) subtest 5","Range: 0 to 3. Interpretation: Higher scores indicate better motor programming and cognitive flexibility, reflecting improved frontal lobe function.",{"measure":42,"description":43,"timeFrame":12},"Zarit Burden Interview (ZBI)","Range: 0 to 88 (for the full scale) Interpretation: Higher scores indicate greater caregiver burden.",{"measure":45,"description":46,"timeFrame":12},"Neuropsychiatric Inventory (NPI)","Range: 0 to 144; Higher scores indicate more severe neuropsychiatric symptoms across assessed domains",{"measure":48,"description":49,"timeFrame":12},"Quality of Life Outcome for Patients with Neurologic Conditions (PROMIS)","Range: Standardized T-score, typically 20 to 80; Higher scores can indicate better or worse outcomes depending on the specific domain",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":53,"timePerspective":53,"maskingInfo":55},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":56,"maskingDescription":53,"whoMasked":57},"DOUBLE",[58,59],"INVESTIGATOR","OUTCOMES_ASSESSOR",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Intervention","EXPERIMENTAL","Digital therapeutics session three times per week",[66],"Device: Digital therapeutics session",{"label":68,"type":69,"description":53,"interventionNames":53},"Control","NO_INTERVENTION",[71],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":53},"DEVICE","Digital therapeutics session","During the digital therapeutics session, the patient performs tasks by handling objects according to instructions displayed by the device. A camera records the task performance, and the system analyzes the task performance.",[62],[77,82],{"name":78,"role":79,"phone":80,"phoneExt":53,"email":81},"Tian-Shin Yeh, MD, MMSc, PhD","CONTACT","+886978730373","tianshin.yeh@gmail.com",{"name":83,"role":79,"phone":84,"phoneExt":53,"email":85},"Jowy Tani, MD, PhD","+886965562798","jowytani@tmu.edu.tw",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":53,"geoPoint":53,"contacts":95},"Taipei Medical University Wan Fang Hospital","RECRUITING","Taipei City","Taipei","116","Taiwan","TW",[96,98,99,101],{"name":97,"role":79,"phone":80,"phoneExt":53,"email":81},"Tian-Shin Yeh, MD, PhD",{"name":83,"role":79,"phone":84,"phoneExt":53,"email":85},{"name":97,"role":100,"phone":53,"phoneExt":53,"email":53},"PRINCIPAL_INVESTIGATOR",{"name":83,"role":100,"phone":53,"phoneExt":53,"email":53},{"type":103,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100576297",false,"NCT06783465","AI-Driven Cognitive Digital Therapeutics for Dementia Management","AI-Driven Generative Content and Precision Dynamic Executive Function Cognitive Digital Therapeutics System for Dementia Management","Inclusion Criteria:\n\n1. Age at least 50 years old.\n2. Clinical Dementia Rating from 0.5-1\n3. Physician diagnosed mild neurocognitive disorder or dementia (according to ICD-11 diagnostic criteria)\n\nExclusion Criteria:\n\n1. Mini-mental state examination score below 18\n2. If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 4 weeks prior to Baseline.\n3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's mild neurocognitive disorder or dementia.\n4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.\n5. Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant.\n6. Geriatric Depression Scale (GDS) score greater than or equal to 10 at Screening.\n7. Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm.","ALL","50 Years",{"count":113,"type":114},30,"ESTIMATED","INTERVENTIONAL",[117],"NA","The study would investigate the effect of a cognitive digital therapeutics system. The intervention group would receive three digital therapeutics sessions per week for 8 weeks, while the control group would receive usual care. Evaluations would be done at baseline, week 8, and week 16.",[120],"Cognitive Impairment","2025-02-17",{"date":123,"type":124},"2025-02-19","ACTUAL",{"date":126,"type":124},"2025-02-01",{"date":128,"type":114},"2026-06",{"name":5,"class":6},1]