Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-26 @ 9:02 AM
Study NCT ID:
NCT05633095
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Trail Making Test Black & White Score : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Trail Making Test Black \\& White Score'}], 'secondaryOutcomes': [{'measure': 'Change of Attention Questionnaire Scale : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Attention Questionnaire Scale'}, {'measure': 'Change of Neuropsychiatric Inventory Score : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Neuropsychiatric Inventory score'}, {'measure': 'Change of Quality of life-AD Score : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Quality of life-AD Score'}, {'measure': 'Change of MMSE-II Score : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by MMSE-II Score'}, {'measure': 'change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'change of beta-amyloid deposition with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by Amyloid PET-CT'}, {'measure': 'Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare glucose metabolic rate with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by FDG PET-CT'}, {'measure': 'Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5', 'timeFrame': 'Week 5', 'description': 'Compare Aβ oligomer density with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by MDS-OAβ test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia, Mild', 'Cognitive Disorder Mild']}, 'descriptionModule': {'briefSummary': "This clinical trial aims to explore the effectiveness and safety of cognitive function improvement of Neuclare, a science medical device, for patients with mild cognitive impairment and early Alzheimer's disease.\n\nThrough methods such as Trail Making Test Black \\& White, Attention Questionnaire Scale(AQS), Neuropsychiatric Inventory (NPI), etc, cognitive function improvement before and after using Neuclare will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 55 to 90\n* Patients who meet "Probable Alzheimer\'s disease" and "Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)" criteria for dementia\n* Patients with CDR (clinical dementia rating) from 0.5 to 1 and MMSE-II over 18\n* Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions\n\nExclusion Criteria:\n\n* Patient with pathological lesions in the brain identified by 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 epileptic seizures or depression or psychiatric abnormalities or with visual acuity and fluctuations in cognitive decline\n* History of psychiatric disorder other than the inclusion criteria.\n* A person with a severe history of cancer/tuberculosis\n* A person who has or is taking psychiatric or peripheral/central nervous system drugs\n* A person who has contact dermatitis or sensitive skin abnormalities\n* Patients with a high fever of 40 degrees or higher based on eardrum body temperature\n* A person whose bleeding is identified within the last 3 months due to a common procedure/surgery that may affect vital signs\n* A person who is unable to perform MRI tests\n* Pregnant women\n* Patient with calcification in the brain identified by CT\n* Patient with allergic to contrast agents such as Definity or Gadovist\n* Other cases where the investigator judged that it is difficult to participate in the study;'}, 'identificationModule': {'nctId': 'NCT05633095', 'briefTitle': 'The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Deepsonbio'}, 'officialTitle': 'A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia', 'orgStudyIdInfo': {'id': 'Deepsonbio_Neuclare'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare', 'interventionNames': ['Device: Neuclare']}], 'interventions': [{'name': 'Neuclare', 'type': 'DEVICE', 'description': 'It is used to stimulate the brain for a certain period of time to improve cognitive impairment in patients with cognitive disorder. In this clinical trial, it is used for patients with mild cognitive disorder and demincia symptoms.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18450', 'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seonkyu Kim', 'role': 'CONTACT', 'email': 'ksksbs@deepsonbio.com', 'phone': '+82 10-4324-5147'}, {'name': 'Jaeho Kim, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seonkyu Kim', 'role': 'CONTACT', 'email': 'ksksbs@deepsonbio.com', 'phone': '+82-10-4324-5147'}, {'name': 'SangYun Kim, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Seonkyu Kim', 'role': 'CONTACT', 'email': 'ksksbs@deepsonbio.com', 'phone': '+82-10-4324-5147'}], 'overallOfficials': [{'name': 'SangYun Kim, M.D. ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deepsonbio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}