Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 11:46 PM
Study NCT ID:
NCT01256905
Status:
WITHDRAWN
Last Update Posted:
2021-08-23
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI departure from institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2011-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parkinsons Disease', 'Lewy Bodies Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://parkinson.med.nyu.edu/', 'label': 'armodafinil'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in the attention commonly reported by patients with more advanced Parkinson's disease (PD) and Lewy body disease (LBD).", 'detailedDescription': 'The main aims of this study are:\n\n1\\. To investigate whether in PDD and DLB th specific disturbances in the basal ganglia thalamocortical network, measured through the Electroencephalography (EEG) frequency analysis, are ameliorated by armodafinil.\n\nOur main hypothesis is that armodafinil can restore the attention and improve cognitive disturbances in PDD and DLB, through a specific effect on striatal-thalamo-cortical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established criteria for diagnosis of PDD (Parkinsons Disease) {Emre M et al. Mov Disord 2007;22:1689-707} and DLB (Lewy Bodies Disease) {McKeith et al. Neurology 2005;65:1863-72}\n* Mini Mental State Examination (MMSE) score between \\<24; and/or Dementia Rating\n* Scale-2 (DRS-2) score \\<134;\n* Clinical Assessment of Fluctuation (CAF)\\>4;\n* Stable anti-parkinsonian medication in the 4 weeks preceding the study\n\nExclusion Criteria:\n\n* Use of cognitive enhancers (Donepezil, Rivastigmine, Galantamine, Modafinil, Memantine) in the last 4 weeks:\n\nConcomitant use of any medication contraindicated with modafinil/armodafinil; History of alcohol and substances abuse. Use of medications known to alter the normal EEG activity in humans during the study period (i.e. clonazepam) History of psychiatric disorders, other than depression and psychiatric complication of PDD and DLB'}, 'identificationModule': {'nctId': 'NCT01256905', 'acronym': 'Armodafinil', 'briefTitle': "Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies", 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': "Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies", 'orgStudyIdInfo': {'id': '09-0189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Armodafinil', 'interventionNames': ['Drug: Armodafinil']}], 'interventions': [{'name': 'Armodafinil', 'type': 'DRUG', 'description': 'Armodafinil 150 mg', 'armGroupLabels': ['Armodafinil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Parkinsons and Movement Disorders Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sara Varanese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Parkinsons and Movement Disorders Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cephalon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}