Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-25 @ 3:56 PM
Study NCT ID:
NCT02848404
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Application usage log', 'timeFrame': '4-weeks treatment', 'description': 'Log to assess compliance of participant(by describing frequency and duration of training by using application)'}], 'secondaryOutcomes': [{'measure': 'Subjective Memory Complaint Questionnaire', 'timeFrame': 'after 4-weeks treatment', 'description': 'to evaluate efficacy of application'}, {'measure': 'Geriatric Depression Scale', 'timeFrame': 'after 4-weeks treatment', 'description': 'to evaluate efficacy of application'}, {'measure': 'Korean version of MMSE for dementia screening', 'timeFrame': 'after 4-weeks treatment', 'description': 'to evaluate efficacy of application'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild cognitive impairment', 'Cognitive rehabilitation', 'Cognitive therapy', "Alzheimer's disease", 'Memory enhancement', 'Categorical language fluency'], 'conditions': ['Mild Cognitive Impairment', "Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine therapeutic efficacy of categorical language fluency smartphone game application in mild cognitive impairment and mild Alzheimer's dementia.", 'detailedDescription': "The Categorical Language Fluency Smartphone Game Application was developed based on the semantic distance training, which was effective in improving categorical language fluency of mild cognitive impairment and mild Alzheimer's dementia. 10 patients with mild cognitive impairment and another 10 patients with mild Alzheimer's dementia were recruited to examine therapeutic efficacy of the application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged above 55\n* Confirmed literacy\n\n * Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.\n * Diagnosed to possible or probable Alzheimer's dementia by NINCDS-ADRDA and Clinical Dementia Rating(CDR) of 1 or below.\n\nExclusion Criteria:\n\n* Evidence of delirium, confusion\n* Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus\n* Evidence of severe cerebrovascular pathology\n* History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity\n* History of substance abuse or dependence such as alcohol\n* Presence of depressive symptoms that could influence cognitive function\n* Presence of medical comorbidities that could result in cognitive decline"}, 'identificationModule': {'nctId': 'NCT02848404', 'briefTitle': 'Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': "A Study of Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application in Mild Cognitive Impairment and Mild Alzheimer's Dementia (Baseline Study)", 'orgStudyIdInfo': {'id': '2010-0028631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Categorical Language Fluency Smartphone Application', 'description': 'Smartphone game application specifically aimed at training categorical language fluency', 'interventionNames': ['Device: Categorical Language Fluency Smartphone Application']}], 'interventions': [{'name': 'Categorical Language Fluency Smartphone Application', 'type': 'DEVICE', 'description': "4 weeks' training", 'armGroupLabels': ['Categorical Language Fluency Smartphone Application']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ki Woong Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital, Seong-nam, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University', 'class': 'OTHER'}, {'name': 'Ministry of Science and ICT, Republic of Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, department of neuropsychiatry', 'investigatorFullName': 'Ki Woong Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}