[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Deepsonbio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100611340","neuclare-device-for-temporary-improvement-of-executive-function-in-patients-with-mild-cognitive-impairment-and-prodromal-alzheimers-disease-100611340",false,"NCT07239310","Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease","A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Confirmatory Clinical Trial to Verify the Efficacy and Safety of the Cognitive Improvement Effect on Executive Function in Medication-Treated Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease Using the Neuclare Physical Device for Medical Use","Inclusion Criteria:\n\n1. Adults aged 55 to 90 years.\n2. Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,\n3. or mild cognitive impairment\u002Fvery mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.\n4. On stable cognitive therapy medications for at least 1 month.\n5. Voluntary participation with signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).\n2. Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic\u002Frenal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs).\n3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.\n4. Patients with psychiatric disorders outside of the inclusion criteria.\n5. Patients with a history of severe diseases such as cancer or tuberculosis.\n6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.\n7. Patients with contact dermatitis or other skin hypersensitivity conditions.\n8. Patients with fever ≥ 40°C as measured by tympanic temperature.\n9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.\n10. Patients unable to undergo MRI.\n11. Pregnant patients.\n12. Patients with clinical brain calcification observed on computed tomography (CT) scans.\n13. Patients with known allergies to contrast agents such as Definity or Gadovist.\n14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.","ALL","55 Years","90 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease.\n\nParticipants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study.\n\nDuring the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L).\n\nThe goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.",[27,28],"Mild Cognitive Impairment","Alzheimer's Disease(AD)","RECRUITING","2025-12-08",{"date":32,"type":33},"2025-12-10","ACTUAL",{"date":35,"type":33},"2025-11-20",{"date":37,"type":21},"2026-07",{"name":39,"class":40},"Deepsonbio","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100552891","the-pilot-study-of-medical-device-neuclare-for-patients-with-idiopathic-normal-pressure-hydrocephalus-inph-100552891","NCT06478979","The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)","A Prospective, Single-arm, Open-label, Non-randomized Exploratory Clinical Trial to Verify the Efficacy and Safety of Gait and Cognitive Improvement in Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH) Using the Neuclare Physical Device for Medical Use","Inclusion Criteria:\n\n* Adults aged 60 to 90, regardless of gender\n* Individuals exhibiting gait disturbances along with at least one of the following symptoms: cognitive impairment or urinary incontinence\n* Evans' index \\> 0.3)\n* When the symptoms in 2) and 3) cannot be fully explained by other neurological or non-neurological diseases\n* Diagnosis of INPH based on the Investigator's clinical judgement based on criteria as described in the INPH Guidelines\n\nExclusion Criteria:\n\n* Patient with pathological lesions in the brain identified by MRI\n* A person who is confirmed to have organic brain lesions (e.g., cerebral edema, cerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.) on a brain MRI.\n* Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs)\n* History of psychiatric disorder other than the inclusion criteria.\n* A person with a severe history of cancer\u002Ftuberculosis\n* A person who has contact dermatitis or sensitive skin abnormalities\n* Patients with a high fever of 40 degrees Celsius or higher based on eardrum body temperature\n* A person whose bleeding is identified due to a common procedure or surgery that may affect vital signs\n* A person who is unable to perform MRI tests\n* A person with an allergic reaction to MRI contrast agents such as Definity or Gadovist.\n* Other cases where the investigator judged that it is difficult to participate in the study\n* Patient with behavioral and psychological symptoms of dementia (BPSD) that make cooperation in the clinical trial difficult\n* Patients with severe cognitive impairment, defined as an MMSE score of 17 or below\n* Patients who have undergone shunt surgery in the past year\n* Patients with a history of uncontrolled thyroid, liver, or kidney dysfunction\n* Patients taking medications that affect gait, cognition, or urinary tract function and who have had a change in medication regimen within the past 3 months.\n* Patients who have undergone a cerebrospinal fluid drainage test within the past 1 month.","60 Years",{"count":51,"type":21},20,[24],"This clinical trial aims to explore the effectiveness and safety of gait improvemen of Neuclare, a science medical device, for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH) Through methods such as Timed Up \\& Go Test (TUG), 10m gait , iNPH grading scale), etc, gait improvement before and after using Neuclare will be evaluated.",[55],"Idiopathic Normal Pressure Hydrocephalus (iNPH)","2024-12-26",{"date":58,"type":33},"2024-12-30",{"date":60,"type":33},"2024-07-22",{"date":62,"type":21},"2026-01-01",{"name":39,"class":40},1,""]