Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 10:09 PM
Study NCT ID:
NCT01212692
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mental Stimulation in Patients With Mild Cognitive Impairment
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Ordered Pointing Task', 'timeFrame': 'baseline'}, {'measure': 'Trail-Making', 'timeFrame': 'baseline'}, {'measure': 'Timed Instrumental Activities of Daily Living', 'timeFrame': 'baseline'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': 'baseline'}, {'measure': 'Self-ordered pointing task', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Self-ordered pointing task', 'timeFrame': '3 months post intervention'}, {'measure': 'Self-ordered pointing task', 'timeFrame': '9 months post-intervention'}, {'measure': 'Trail-Making', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Trail-Making', 'timeFrame': '3 months post-intervention'}, {'measure': 'Trail-Making', 'timeFrame': '9 months post-intervention'}, {'measure': 'Timed Instrumental Activities of Daily Living', 'timeFrame': 'immediately after the intervention'}, {'measure': 'Timed Instrumental Activities of Daily Living', 'timeFrame': '3 months post-intervention'}, {'measure': 'Timed Instrumental Activities of Daily Living', 'timeFrame': '9 months post-intervention'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': 'immediately after the intevention'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': '3 months post-intervention'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': '9 months post-intervention'}], 'secondaryOutcomes': [{'measure': 'Clinical Dementia Rating Scale', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Digit Symbol Substitution Test', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Digit Span', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Verbal Fluency Test', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Geriatric Depression Scale', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Neuropsychiatric Inventory', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Recollection Task', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'N-Back', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Rivermead Behavioral Memory Test', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Instrumental Activities of Daily Living', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Functional Capacities for Activities of Daily Living', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}, {'measure': 'Multifactorial Memory Questionnaire', 'timeFrame': 'baseline, immediately after the intervention, 3 months post intervention, and 9 months post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment (MCI)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with Mild Cognitive Impairment. The study will compare the effects of different methods of mental stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 50 years of age\n* meet criteria for amnestic-Mild Cognitive Impairment (MCI)\n* have capacity to give informed consent\n* have capacity to complete assessment measures\n\nExclusion Criteria:\n\n* history of drug or alcohol dependence\n* severe psychiatric conditions associated with psychosis (e.g., schizophrenia)\n* recent stroke\n* clinical diagnosis of probable Alzheimer's Disease\n* history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., Parkinson's Disease, Korsakoff's, HIV)\n* current use of Alzheimer's Disease medications (e.g., cholinesterase inhibitors, memantine)"}, 'identificationModule': {'nctId': 'NCT01212692', 'briefTitle': 'Effects of Mental Stimulation in Patients With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Theoretically Based Memory Training Intervention in Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'NA_00039100'}, 'secondaryIdInfos': [{'id': 'R01AG034934', 'link': 'https://reporter.nih.gov/quickSearch/R01AG034934', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentally stimulating activities', 'interventionNames': ['Behavioral: mentally stimulating activities']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mentally stimulating activities- other', 'interventionNames': ['Behavioral: mentally stimulating activities']}], 'interventions': [{'name': 'mentally stimulating activities', 'type': 'BEHAVIORAL', 'description': 'The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.', 'armGroupLabels': ['Mentally stimulating activities', 'Mentally stimulating activities- other']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'BPRU, Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Paul B Rosenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Paul B. Rosenberg', 'investigatorAffiliation': 'Johns Hopkins University'}}}}