[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644642":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":51,"responsibleParty":76,"collaborators":80,"id":83,"slug":55,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":55,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":55,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":53,"whyStopped":55,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"National Defense Medical Center, Taiwan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Far-Infrared (FIR) Therapy","EXPERIMENTAL","Participants will receive active far-infrared (FIR) therapy using a head-mounted FIR device (Yin Fu Rui De Far-Infrared Therapy Device, Model CE-1889).\n\nThe device delivers far-infrared irradiation (4-14 μm) and is applied to Fengfu (GV16) and Baihui (GV20) acupoints for 30 minutes per site, once daily for 12 months.\n\nThe intervention will be initiated under supervised training at the study site, followed by home-based self-administration by participants and\u002For caregivers. Participants will continue their usual medical care without changes to standard pharmacological treatment.",[13],"Device: Yin Fu Rui De Far-Infrared Radiator",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Control","SHAM_COMPARATOR","Participants will receive a sham intervention using an identical-appearing head-mounted device (Yin FuRui De Far-Infrared Therapy Device, Model CE-1889) with the far-infrared emission function disabled.\n\nThe sham device will be applied to the same acupoints (Fengfu GV16 and Baihui GV20) for 30 minutes per site, once daily for 12 months.\n\nProcedures, duration, and application schedule will be identical to the active treatment group to ensure blinding. The sham device does not emit far-infrared radiation.",[19],"Device: Sham Far-Infrared Radiator",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Yin Fu Rui De Far-Infrared Radiator","The investigational device is a head-mounted far-infrared therapy device manufactured in Taiwan.\n\n* Emission wavelength: 4-14 μm\n* Heating mechanism: ceramic semiconductor heating element\n* Design: head-mounted structure with external housing to reduce energy dissipation\n* Application sites: Fengfu (GV16) and Baihui (GV20)\n\nRegulatory status:\n\nApproved medical device (Medical Device License No. 006083 issued by the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan).\n\nApproved indications include relief of fatigue, improvement of local blood circulation, and reduction of muscle stiffness and neuralgia.\n\nIn this study, the device is used investigationally to evaluate potential effects on cognitive function in patients with Alzheimer's disease dementia.",[9],[27],"Yin Fu Rui De Far-Infrared Radiator (Model CE-1899)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham Far-Infrared Radiator","The sham device is identical in appearance to the active device but without active far-infrared emission.\n\nIt is used to maintain participant blinding and control for non-specific effects in device-based interventions.",[15],[33],"Sham Far-Infrared Device (Model CE-1889)",[35],{"name":36,"affiliation":37,"role":38},"Jiunn-Tay Lee, Ｍ.D.","Trial-Service General Hospital, National Defense Medical University","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Juin-Hong Cherng, Ph.D.","CONTACT","886-2-87923100","18681, 18699","i72bbb@gmail.com",{"name":47,"role":42,"phone":48,"phoneExt":49,"email":50},"Gang-Yi Fan, Ph.D.","886-2-8792-3100","18699","u9310318@gmail.com",[52],{"facility":37,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Taipei",null,"11490","Taiwan","TW",{"type":60,"coordinates":61},"Point",[62,63],121.52639,25.05306,{"lat":63,"lon":62},[66,68,69,71,74],{"name":41,"role":42,"phone":43,"phoneExt":67,"email":45},"18699, 18681",{"name":47,"role":42,"phone":43,"phoneExt":49,"email":50},{"name":70,"role":38,"phone":55,"phoneExt":55,"email":55},"Jiunn-Tay Lee, M.D.",{"name":72,"role":73,"phone":55,"phoneExt":55,"email":55},"Chia-Lin Tsai, Ph.D.","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":55,"phoneExt":55,"email":55},"Chia-Kuang Tsai, Ph.D.",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Juin-Hong Cherng","Associate Professor",[81],{"name":82,"class":6},"Tri-Service General Hospital","100644642",false,"NCT07672171","Far-Infrared Therapy for the Effect of Alzheimer Disease Dementia","To Explore the Effect of Far Infrared Therapy on Cognitive Function of Patients With Dementia","Inclusion Criteria:\n\n1. Diagnosed with Alzheimer's disease dementia.\n2. Mini-Mental State Examination (MMSE) score between 18 and 24 (inclusive).\n3. Currently prescribed and maintained on a stable regimen of anti-dementia medication.\n4. No sensory deficits or impairment regarding skin temperature perception.\n5. Patient or a Legally Authorized Representative (LAR) must be willing and capable of providing written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n1. Non-Alzheimer's disease dementia (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia).\n2. Known hypersensitivity to heat or light, including the current use of photosensitizing medications.\n3. Diminished thermal or heat sensitivity, such as from the concurrent use of analgesics, sedatives, or consumption of alcoholic beverages.\n4. Acute injury or acute localized inflammation, including active inflammation, infection, or ulcerated wounds.\n5. Concomitant acute venous thrombosis, varicose veins, severe peripheral arterial occlusive disease (Stage III or IV), lymphatic disease, acute rheumatoid arthritis, acute gout, or active fever.\n6. Presence of mottled erythema or other abnormal dermatological conditions on the scalp or neck.\n7. Localized skin lesions, damage, or open wounds at the device contact sites.\n8. Concurrent participation in any other clinical trial.\n9. Any other underlying pathological conditions or clinical statuses that, based on medical consensus, would preclude safe participation in the study.\n10. Failure or refusal to provide signed informed consent.\n11. Inability or unwillingness to comply with the trial protocols, schedules, or required follow-up evaluations.\n12. History or presence of hemorrhagic disorders or bleeding-related diseases.","ALL","61 Years","92 Years",{"count":93,"type":94},40,"ESTIMATED","INTERVENTIONAL",[97],"NA","Alzheimer's disease (AD), the most common cause of dementia, is a progressive neurodegenerative disorder characterized by cognitive decline, including impaired learning ability, memory loss, and behavioral disturbances.\n\nAccording to surveys conducted by the Ministry of Health and Welfare in Taiwan, the prevalence of dementia among individuals aged 65 years and older was estimated at 7.86% in 2018, affecting more than 280,000 individuals, and is projected to approach 900,000 by 2065, resulting in substantial medical, social, and economic burdens. Current pharmacological treatments provide only limited symptomatic benefits and may be associated with adverse effects. Therefore, safe and effective non-pharmacological interventions that may support cognitive function and reduce caregiver burden are urgently needed.\n\nExperimental studies suggest that far-infrared (FIR) irradiation may enhance mitochondrial oxidative phosphorylation, increase ATP production, and promote microglial amyloid-β clearance, which may help delay the progression of Alzheimer's disease.\n\nThis trial aims to investigate the safety and effects of far-infrared (FIR) therapy on cognitive function in patients with Alzheimer's disease.\n\nThe findings may support the clinical application of FIR therapy as a non-pharmacological intervention to improve cognitive function and quality of life, reduce medication burden and treatment-related side effects, lessen caregiver burden, delay institutionalization, and reduce the social and economic burden associated with Alzheimer's disease.",[100,101],"Dementia","Alzheimer Disease",[103,100,104],"Far-infrared therapy","Alzheimer disease","2026-06-23",{"date":107,"type":108},"2026-06-26","ACTUAL",{"date":110,"type":108},"2022-10-15",{"date":112,"type":94},"2029-10-31",{"name":78,"class":6},1]