Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-17 @ 5:41 PM
Study NCT ID:
NCT00611312
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2008-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2008-01-28', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE', 'timeFrame': '2 weeks with FU at 2 and 4 months'}], 'secondaryOutcomes': [{'measure': 'Brain activity during functional brain imaging', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Cognitive training'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.', 'detailedDescription': 'Twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fMRI). Scanning will be done while subjects perform a verbal learning task. Ten subjects will be scanned before and after the two week training. Another ten will be scanned twice at a two week interval before beginning the cognitive training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)\n\nExclusion Criteria:\n\n* Neurologic disorder other than Alzheimer's disease"}, 'identificationModule': {'nctId': 'NCT00611312', 'briefTitle': "Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IIRG-07-57789'}, 'secondaryIdInfos': [{'id': '11008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cognitive Training', 'interventionNames': ['Behavioral: Cognitive Training']}], 'interventions': [{'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': 'Intense cognitive training, two consecutive weeks, each weekday, 6 hours/day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Yvonne Colgrove, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Association", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yvonne Colgrove, PT, PhD', 'investigatorAffiliation': 'University of Kansas'}}}}