Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-27 @ 3:21 PM
Study NCT ID:
NCT04533204
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
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False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mnemonic Strategy Training', 'description': 'Training using mnemonic strategies\n\nmnemonic strategy training: training using mnemonic strategies', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spaced Retrieval Training', 'description': 'Training using spaced retrieval\n\nspaced retrieval training: training using spaced retrieval', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mnemonic Strategy Training', 'description': 'Training using mnemonic strategies\n\nmnemonic strategy training: training using mnemonic strategies'}, {'id': 'OG001', 'title': 'Spaced Retrieval Training', 'description': 'Training using spaced retrieval\n\nspaced retrieval training: training using spaced retrieval'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '74.86', 'upperLimit': '85.14'}, {'value': '62.45', 'groupId': 'OG001', 'lowerLimit': '57.4', 'upperLimit': '67.51'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.47', 'ciLowerLimit': '12.28', 'ciUpperLimit': '24.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 month after last training session', 'description': 'Change in memory for 45 trained object location associations', 'unitOfMeasure': 'percent correct', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Accuracy (vs. Baseline) on Novel Object Location Associations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mnemonic Strategy Training', 'description': 'Training using mnemonic strategies\n\nmnemonic strategy training: training using mnemonic strategies'}, {'id': 'OG001', 'title': 'Spaced Retrieval Training', 'description': 'Training using spaced retrieval\n\nspaced retrieval training: training using spaced retrieval'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '7.4'}, {'value': '7.14', 'groupId': 'OG001', 'lowerLimit': '5.84', 'upperLimit': '8.44'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '.75', 'ciUpperLimit': '3.91', 'pValueComment': 'Performance on cued recall (error scores)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 month after last training session', 'description': 'Change in accuracy for novel object location associations using a touchscreen task; distance measured in cm from actual location', 'unitOfMeasure': 'error in centimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Computer errors resulted in loss of data from the first 15 participants (7 MST, 8 SRT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mnemonic Strategy Training', 'description': 'Training using mnemonic strategies\n\nmnemonic strategy training: training using mnemonic strategies'}, {'id': 'FG001', 'title': 'Spaced Retrieval Training', 'description': 'Training using spaced retrieval\n\nspaced retrieval training: training using spaced retrieval'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Unable to understand training instructions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mnemonic Strategy Training', 'description': 'Training using mnemonic strategies\n\nmnemonic strategy training: training using mnemonic strategies'}, {'id': 'BG001', 'title': 'Spaced Retrieval Training', 'description': 'Training using spaced retrieval\n\nspaced retrieval training: training using spaced retrieval'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in each group was removed due to inability to understand training instructions'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '70.5', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '71.6', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant in each group removed due to inability to understand training instructions'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in each group removed due to inability to understand training instructions'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in each group removed due to inability to understand training instructions'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All diagnosed with amnestic MCI.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were informed they would receive one of two cognition oriented treatments but were unaware of the nature of the other intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to Mnemonic strategy or spaced retrieval training'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2014-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2020-08-25', 'resultsFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-26', 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment', 'timeFrame': 'up to 1 month after last training session', 'description': 'Change in memory for 45 trained object location associations'}], 'secondaryOutcomes': [{'measure': 'Change in Accuracy (vs. Baseline) on Novel Object Location Associations', 'timeFrame': 'up to 1 month after last training session', 'description': 'Change in accuracy for novel object location associations using a touchscreen task; distance measured in cm from actual location'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MCI', 'cognitive training', 'memory training', 'dementia', "Alzheimer's disease"], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.', 'detailedDescription': 'Individuals with MCI were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. Across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. Task-fMRI was acquired before and after training. Memory was again evaluated 1 month after the last training session. The primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the MRI environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Diagnosis of MCI according to Petersen (2004) criteria, right handed\n\nExclusion Criteria:\n\n* Diagnosis of other neurological condition,\n* active drug/alcohol abuse/dependence,\n* moderate-severe depression or other Axis I diagnoses.'}, 'identificationModule': {'nctId': 'NCT04533204', 'acronym': 'MST training', 'briefTitle': 'Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Comparing Mnemonic Strategy With Spaced Retrieval Training in Patients With Mild Cognitive Impairment (B6366-W)', 'orgStudyIdInfo': {'id': 'B6366-W-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mnemonic strategy training', 'description': 'Training using mnemonic strategies', 'interventionNames': ['Behavioral: mnemonic strategy training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spaced retrieval training', 'description': 'Training using spaced retrieval', 'interventionNames': ['Behavioral: spaced retrieval training']}], 'interventions': [{'name': 'mnemonic strategy training', 'type': 'BEHAVIORAL', 'description': 'training using mnemonic strategies', 'armGroupLabels': ['Mnemonic strategy training']}, {'name': 'spaced retrieval training', 'type': 'BEHAVIORAL', 'description': 'training using spaced retrieval', 'armGroupLabels': ['Spaced retrieval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Benjamin M. Hampstead, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}