Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-19 @ 3:58 PM
Study NCT ID:
NCT05634161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MMSE', 'timeFrame': 'Single-point evaluation (baseline)'}], 'primaryOutcomes': [{'measure': 'Usability: Based on scenarios', 'timeFrame': 'Single-point evaluation (baseline)'}], 'secondaryOutcomes': [{'measure': 'Usability: Based on user survey', 'timeFrame': 'Single-point evaluation (baseline)'}, {'measure': 'Usability: Based on hemodynamic responses', 'timeFrame': 'Single-point evaluation (baseline)'}, {'measure': 'Changes in Adas-cog', 'timeFrame': 'After 12 weeks of system usage'}, {'measure': 'Changes in ADCS-ADL', 'timeFrame': 'After 12 weeks of system usage'}, {'measure': 'Changes in self-reported quality of life', 'timeFrame': 'After 12 weeks of system usage'}, {'measure': 'Changes in blood biomarker', 'timeFrame': 'After 12 weeks of system usage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cognitively Impaired patients aged 55 to 85, based in South Korea.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and Female patients, 55\\~85 years\n* Adequate vision, hearing and speaking for neuropsychological testing\n* No difficulty in using mobile application using smartphone\n* Patients with subjective memory complaints, confirmed by informants\n* Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery\n* Global CDR 0.5 \\~ 1\n* Korean speaker\n* Have an identified trial partner\n* All subjects signed written consent\n\nExclusion Criteria:\n\n* Those unable to provide consent\n* History of transient ischemic attack, stroke, brain tumor\n* History of diagnosis of major depression\n* Symptoms that may interfere with the subject's testing procedure\n* Cerebral hemorrhage\n* Central nervous system infections\n* Prohibited concomitant medication\n* Known or suspected history of drug or alcohol abuse"}, 'identificationModule': {'nctId': 'NCT05634161', 'briefTitle': 'Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study', 'orgStudyIdInfo': {'id': '20-2022-48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cognitive Improvement software', 'description': 'Usability assessment of cognitive improvement software', 'interventionNames': ['Other: Cognitive improvement software']}], 'interventions': [{'name': 'Cognitive improvement software', 'type': 'OTHER', 'description': 'Cognitive improvement software', 'armGroupLabels': ['Cognitive Improvement software']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun-Young Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun Young Lee', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}