Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-29 @ 10:32 AM
Study NCT ID:
NCT01525368
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2012-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Predictors of a Cognitive Intervention in aMCI
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-11', 'studyFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in California Verbal Learning Test', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in overall cognition (ADAScog)', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in Face-Name Learning Test', 'timeFrame': 'month 0 and month 6'}], 'secondaryOutcomes': [{'measure': 'Change in appraisal of quality of life (SF-36)', 'timeFrame': 'month 0 and 6'}, {'measure': 'Change in neurofunctional MRT (resting state fMRI)', 'timeFrame': 'month 0 and 6'}, {'measure': 'Change in depression scores (Beck Depression Inventory)', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in working memory (Digit Span)', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in attention (Trail Making Test)', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in executive functions (Stroop Test)', 'timeFrame': 'month 0 and month 6'}, {'measure': 'Change in neurostructural MRI (diffusion tensor imaging)', 'timeFrame': 'month 0 and month 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment', "Alzheimer's disease", 'cognitive intervention', 'cognitive reserve'], 'conditions': ['Amnestic Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.\n\nPrevious studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.\n\nThe investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).\n\nFor comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive aMCI patients of an University-based memory clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)\n* No evidence for other psychiatric axis I disorders according to DSM-IV criteria.\n* No evidence for neurological disorders (e.g. stroke)\n* No uncontrolled arterial hypertension or diabetes mellitus\n* No history of drug / alcohol abuse\n* The patient is able to provide written informed consent to participate in the study.\n* for the cognitive-reserve-study patients, a high (low) cognitive reserve is defined as a verbal IQ score of \\>/= 120 (\\</= 110) as assessed by the MWT-B, a German multiple vocabulary test\n\nExclusion Criteria:\n\n* Evidence for acute psychiatric or neurological disorders\n* Uncontrolled arterial hypertension or diabetes mellitus\n* History of drug / alcohol abuse\n* No ability to participate and no willing to give informed consent and comply with the study restrictions.'}, 'identificationModule': {'nctId': 'NCT01525368', 'acronym': 'OutPreC MCI', 'briefTitle': 'Outcome Predictors of a Cognitive Intervention in aMCI', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)', 'orgStudyIdInfo': {'id': 'cogT002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cognitive intervention group', 'interventionNames': ['Behavioral: cognitive intervention']}, {'label': 'active control group'}], 'interventions': [{'name': 'cognitive intervention', 'type': 'BEHAVIORAL', 'description': 'Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.', 'armGroupLabels': ['cognitive intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Katharina Buerger, MD, Institute for Stroke and Dementia Research', 'investigatorFullName': 'Katharina Buerger', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}