Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT04919005
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Wechsler Intelligence Scale for Adults (WAIS-III)', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'The WAIS-III is an intellectual assessment that aims to analise the measures of the following Factorial Scales and Indexes: Verbal IQ (intelligence quotient), Execution IQ, Total IQ, Verbal Understanding Index, Perceptual Organization Indexes, Operational Memory Indexes and Processing speed index.'}, {'measure': 'Change on Mini Mental State Examination (MMSE)', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'The MMSE is a data collection instrument widely used in cases of dementia, it evaluates temporal and spatial orientation, short-term memory (immediate or attention) and skills of evocation, calculation, praxis, visuospatial, communication and language.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.", 'detailedDescription': "SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with physical or psychological conditions allow interacting with digital games;\n* Elderly over 60 years with mild Alzheimer;\n* Seniors over 60 Healthy;\n* Healthy Youth;\n\nExclusion Criteria:\n\n* People without physical or psychological conditions allow interacting with digital games;\n* Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;'}, 'identificationModule': {'nctId': 'NCT04919005', 'briefTitle': "Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's", 'organization': {'class': 'OTHER', 'fullName': 'University of Mogi das Cruzes'}, 'officialTitle': "Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's", 'orgStudyIdInfo': {'id': 'CAAE: 54290416.9.0000.5497'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy elderly people', 'description': 'Twelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.', 'interventionNames': ['Other: Virtual Environment']}, {'type': 'EXPERIMENTAL', 'label': "Elderly people with Alzheimer's in the initial phase", 'description': "Seven elderly people with Alzheimer's in the initial phase. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.", 'interventionNames': ['Other: Virtual Environment']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy young people', 'description': 'Fifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.', 'interventionNames': ['Other: Virtual Environment']}], 'interventions': [{'name': 'Virtual Environment', 'type': 'OTHER', 'description': 'The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.', 'armGroupLabels': ["Elderly people with Alzheimer's in the initial phase", 'Healthy elderly people', 'Healthy young people']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08780-911', 'city': 'Mogi das Cruzes', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Terigi Augusto Scardovelli', 'geoPoint': {'lat': -23.52278, 'lon': -46.18833}}], 'overallOfficials': [{'name': 'Marcia A Bissaco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mogi das Cruzes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mogi das Cruzes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Terigi Augusto Scardovelli', 'investigatorAffiliation': 'University of Mogi das Cruzes'}}}}