Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 2:15 AM
Study NCT ID:
NCT01646333
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2012-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2012-07-13', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 6 Months', 'timeFrame': 'Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 6 months', 'description': 'Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 6 months'}, {'measure': 'Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 6 Months', 'timeFrame': 'Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 6 months', 'description': 'Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 6 months'}], 'primaryOutcomes': [{'measure': 'California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 10 Weeks', 'timeFrame': 'Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 10 weeks', 'description': 'Change in California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 10 weeks'}], 'secondaryOutcomes': [{'measure': 'Linear Analog Scale Assessment Overall Well Being Raw Score Change Over 10 Weeks', 'timeFrame': 'Change from Baseline in Linear Analog Scale Assessment Overall Well Being Raw Score at 10 weeks', 'description': 'Change in Linear Analog Scale Assessment Overall Well Being Raw Score from Baseline and 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Mild Cognitive Impairment', 'Cognition', 'Executive Function', 'Learning', 'Memory', 'Problem Solving'], 'conditions': ["Parkinson's Disease", 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "This randomized, controlled trial (RCT) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with Parkinson's Disease with Mild Cognitive Impairment (MCI) and their support persons. Participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. A 6-month follow up evaluation will establish if benefits remain over time. Impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. The memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. Both conditions are hypothesized to result in improved mood and quality of life ratings.\n\nResults from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with Parkinson's Disease and Mild Cognitive Impairment. If positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with Parkinson's Disease and their support persons.", 'detailedDescription': "The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's Disease\n* Clinical diagnosis of Mild Cognitive Impairment\n\nExclusion Criteria:\n\n* Clinical diagnosis of Dementia\n* Clinical diagnosis of other Parkinson's Disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing"}, 'identificationModule': {'nctId': 'NCT01646333', 'briefTitle': "A Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': "A Randomized Controlled Trial of Neurocognitive and Supportive Therapy Interventions for Individuals With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'PT107964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Therapy', 'description': "The supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both Parkinson's Disease and non-Parkinson's Disease related problems.", 'interventionNames': ['Behavioral: Supportive Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Memory and Problem-Solving Intervention', 'description': 'The memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. The neurocognitive memory intervention was adapted from a 6-week manualized day calendar and note taking system previously evaluated in an amnestic MCI sample and a brain tumor sample. The problem solving intervention was adapted from an originally 12-week intervention, which was later adapted into a 6-week brain tumor sample.', 'interventionNames': ['Behavioral: Memory and Problem-Solving Intervention']}], 'interventions': [{'name': 'Memory and Problem-Solving Intervention', 'type': 'BEHAVIORAL', 'description': '8 weekly 1 hour sessions of memory compensation and problem-solving strategies', 'armGroupLabels': ['Memory and Problem-Solving Intervention']}, {'name': 'Supportive Therapy', 'type': 'BEHAVIORAL', 'description': '8 weekly 1 hour sessions of non-directive supportive therapy.', 'armGroupLabels': ['Supportive Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "VCU Parkinson's and Movement Disorders Center", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Sarah K Lageman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}, {'name': 'James P Bennett, Jr., M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}