[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659287":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":37,"studyPopulation":24,"armGroups":38,"interventions":51,"overallOfficials":24,"centralContacts":60,"locations":66,"responsibleParty":85,"collaborators":24,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":24,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"ReadyCure Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":24},[9,13,15,18,21],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score","Change in ADAS-K-Cog-13 score from baseline will be evaluated at 6 and 12 months. The 13-item cognitive subscale evaluates multiple cognitive domains relevant to Alzheimer's disease. Lower scores indicate better preserved cognitive function.","Baseline to 6 months and 12 months after the intervention",{"measure":14,"description":11,"timeFrame":12},"Change From Baseline in Alzheimer's Disease Assessment Scale-Korea-Cognitive Subscale-13 (ADAS-K-Cog-13) Score",{"measure":16,"description":17,"timeFrame":17},"Change From Baseline in Korean Mini-Mental Status Examination-2 (K-MMSE-2) Score","Change in K-MMSE-2 score from baseline will be evaluated at 6 and 12 months. The K-MMSE-2 is used to assess global cognitive function and changes in cognitive status over time.",{"measure":19,"description":20,"timeFrame":12},"Change From Baseline in Korean Instrumental Activities of Daily Living (K-iADL) Score","Change in K-iADL score from baseline will be evaluated at 6 and 12 months. The K-iADL assesses the participant's ability to perform instrumental activities required for daily living.",{"measure":22,"description":23,"timeFrame":22},"Change From Baseline in Amyloid Burden Measured Using the Centiloid Scale","Change in cerebral amyloid burden from baseline will be assessed at 6 and 12 months. Amyloid PET images will be analyzed to obtain standardized uptake value ratios (SUVRs), which will be converted to the standardized Centiloid scale.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either a low-dose whole-brain radiation therapy group or a sham-control group and will be followed in parallel.","TREATMENT",{"masking":31,"maskingDescription":32,"whoMasked":33},"TRIPLE","Participants, investigators, and outcome assessors will be blinded to treatment assignment. The investigational device managers and device operators will remain unblinded because they are required to configure and operate the device for either active low-dose radiation therapy or the sham procedure. Unblinded personnel will not participate in efficacy or safety assessments.",[34,35,36],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a prospective, single-center, randomized, subject-assessor double-blind, sham-controlled, exploratory clinical trial designed to evaluate changes following treatment with HeLaXON in patients with mild Alzheimer's disease dementia.\n\nThirty eligible participants will be randomly assigned in a 1:1 ratio to an experimental group or a sham-control group. Participants assigned to the experimental group will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 treatment sessions and a cumulative dose of 0.24 Gy. Participants assigned to the sham-control group will undergo the same positioning, head immobilization, device operation, sound, and lighting procedures, but no radiation will be delivered.\n\nEfficacy assessments include CDR-SB, ADAS-K-Cog-13, K-MMSE-2, K-iADL, and amyloid burden quantified using the Centiloid scale. Changes from baseline will be assessed at 6 and 12 months. Safety assessments include adverse events, vital signs, physical examinations, laboratory tests, neurological examinations, and brain MRI. Exploratory plasma biomarkers including Aβ42\u002F40 ratio, p-tau217, and Aβ oligomer will be assessed at baseline and 12 months.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"HeLaXON 1X Low-Dose Whole-Brain Radiation Therapy","EXPERIMENTAL","Participants will receive low-dose whole-brain radiation therapy using HeLaXON 1X at a dose of 0.04 Gy per session, twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy.",[44],"Device: HeLaXON 1X Low-Dose Radiation Therapy",{"label":46,"type":47,"description":48,"interventionNames":49},"Sham HeLaXON 1X Procedure","SHAM_COMPARATOR","Participants will undergo the same HeLaXON 1X procedures as the experimental group, including treatment positioning, head and neck immobilization, device operation, sound, and lighting, but no radiation will be delivered (0.00 Gy).",[50],"Device: Sham HeLaXON 1X Procedure",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":24},"DEVICE","HeLaXON 1X Low-Dose Radiation Therapy","Low-dose whole-brain X-ray radiation will be delivered using the HeLaXON 1X device at 0.04 Gy per session, twice weekly for 3 weeks. Participants will receive a total of 6 sessions, corresponding to a cumulative radiation dose of 0.24 Gy.",[40],{"type":53,"name":46,"description":58,"armGroupLabels":59,"otherNames":24},"The HeLaXON 1X device will be used with the same participant positioning, head and neck immobilization, device operation, sound, and lighting procedures as the experimental intervention; however, no radiation will be delivered. The total radiation dose will be 0.00 Gy.",[46],[61],{"name":62,"role":63,"phone":64,"phoneExt":24,"email":65},"SangHui BANG, Bachelor's degree","CONTACT","+82-2-959-2021","shbang2364@ready-cure.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":24,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Soonchunhyang University Cheonan Hospital","RECRUITING","Cheonan","Chungcheongnam-do","31151","South Korea",{"type":75,"coordinates":76},"Point",[77,78],127.1522,36.8065,{"lat":78,"lon":77},[81],{"name":82,"role":63,"phone":83,"phoneExt":24,"email":84},"InYoung Jo, PhD","+82-41-570-3550","inyoung.jo@schmc.ac.kr",{"type":86,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100659287","exploratory-study-of-low-dose-whole-brain-radiation-therapy-with-helaxon-1x-in-patients-with-mild-alzheimers-disease-dementia-100659287",false,"NCT07863011","Exploratory Study of Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Patients With Mild Alzheimer's Disease Dementia","A Prospective, Single-Center, Randomized, Subject-Assessor Double-Blind, Sham-Controlled, Exploratory Clinical Trial to Evaluate the Pre- and Post-Treatment Changes of HeLaXON, a Low-Dose Radiation Therapy Device, in Patients With Mild AD Dementia","LDRT-AD-03","Inclusion Criteria:\n\n1. Male or female participants aged 60 to 85 years, inclusive.\n2. Mild dementia (Stage 4) according to the NIA-AA (New Diagnostic Criteria for Alzheimer's Disease) criteria.\n3. At screening, participants must meet all of the following criteria:\n\n   * K-MMSE-2 score of 20 to 26, inclusive.\n   * CDR Global Score of 1, or CDR Global Score of 0.5 or 1 with a CDR-SB score of 4.5 to 9.0, inclusive.\n   * Memory Box Score of at least 0.5.\n4. If receiving a cholinesterase inhibitor (donepezil, galantamine, or rivastigmine) for symptomatic treatment, the participant must have been maintained on a stable dose for at least 12 weeks before the screening visit.\n5. Positive cerebral amyloid accumulation confirmed by amyloid PET.\n6. Able to undergo the cognitive assessments and imaging examinations required by the study.\n7. Has a caregiver who can provide information regarding the participant's overall condition and changes in cognitive and functional status.\n8. Written informed consent for study participation must be obtained from a legally authorized representative. If, based on the investigator's assessment of decision-making capacity, the participant is considered able to understand the purpose and procedures of the study and voluntarily express his or her wishes, written informed consent will also be obtained from the participant.\n\nExclusion Criteria:\n\n1\\. History of prior radiation therapy to the brain. 2. History of seizure within 10 years before the screening date. 4. Presence of a scalp skin disorder. 5. History of hypersensitivity to Vizamyl™ (flutemetamol F 18 injection) or any of its major excipients, including polysorbate 80.\n\nContraindication to MRI, including but not limited to a pacemaker, metallic implant, or severe claustrophobia that prevents MRI examination.\n\n6\\. Diagnosis of a malignant tumor within 5 years before the screening visit or currently receiving treatment for a malignancy.\n\n7\\. Pregnant or breastfeeding. 8. Previous treatment with an anti-amyloid monoclonal antibody without an interval of at least 5 half-lives before the screening visit.\n\n9\\. Cognitive impairment attributable to a condition other than Alzheimer's disease, including drug-related causes or other neurological or neurodegenerative conditions such as substance abuse, vitamin B12 deficiency, thyroid dysfunction, stroke or other cerebrovascular disease, Lewy body dementia, frontotemporal dementia, or traumatic brain injury.\n\n10\\. Clinically significant unstable psychiatric disorder, including uncontrolled depression, schizophrenia, or bipolar disorder, diagnosed within 6 months before screening.\n\n11\\. Any of the following findings on brain MRI:\n\n* Acute or subacute hemorrhage.\n* Prior macrohemorrhage greater than 1 cm in diameter on T2-weighted imaging, or prior subarachnoid hemorrhage, unless it can be documented that the finding is not due to an underlying structural or vascular abnormality and does not suggest a risk of recurrent hemorrhage.\n* More than 4 microhemorrhages.\n* Cortical infarct greater than 1.5 cm in diameter, irrespective of anatomical location.\n* More than 1 lacunar infarct greater than 1.5 cm in diameter.\n* Superficial siderosis.\n* Diffuse white matter disease defined as a score of 3 on the age-related white matter changes scale.\n* Any MRI finding that, in the opinion of the investigator, may contribute to the participant's dementia, pose a risk to the participant, or prevent satisfactory MRI assessment for safety monitoring.\n\n  12\\. Participation in another interventional clinical trial at screening with receipt of an investigational drug or application of an investigational medical device.\n\n  13\\. Any other clinically significant finding that, in the investigator's judgment, makes the participant unsuitable for study participation.\n\n  14\\. Unwilling or unable to use at least one medically acceptable method of contraception throughout the study.","ALL","60 Years","85 Years",{"count":99,"type":100},30,"ESTIMATED","INTERVENTIONAL",[103],"NA","This randomized, sham-controlled, exploratory clinical trial will evaluate the efficacy and safety of HeLaXON, an investigational low-dose radiation therapy device, in patients with mild Alzheimer's disease dementia. A total of 30 participants will be randomly assigned in a 1:1 ratio to receive either low-dose whole-brain radiation therapy or a sham procedure using the same device. Participants in the treatment group will receive 0.04 Gy per session twice weekly for 3 weeks, for a total of 6 sessions and a cumulative dose of 0.24 Gy. Participants in the sham group will undergo the same device procedures without radiation delivery. Participants and outcome assessors will remain blinded to treatment assignment. Changes in cognitive function, dementia severity, daily functioning, and amyloid burden will be evaluated at 6 and 12 months after treatment. Safety will be assessed throughout the study. Exploratory blood biomarkers, including plasma Aβ42\u002F40 ratio, p-tau217, and Aβ oligomer, will also be evaluated.",[106],"Alzheimer Disease",[108,109,110,111,112,113,114,115,116,117,118],"Mild Alzheimer's Disease Dementia","Low-Dose Radiation Therapy","Whole-Brain Radiation Therapy","HeLaXON","HeLaXON 1X","Amyloid PET","Brain MRI","K-MMSE 2","K-iADL","CDR-sb","Neuroinflammation","2026-10-02",{"date":121,"type":122},"2026-10-07","ACTUAL",{"date":124,"type":100},"2026-10-26",{"date":126,"type":100},"2028-12-30",{"name":5,"class":6},1]