Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT00171795
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068836', 'term': 'Rivastigmine'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment"}], 'secondaryOutcomes': [{'measure': 'Safety of rivastigmine'}, {'measure': 'Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating'}]}, 'conditionsModule': {'keywords': ['Traumatic brain injury,', 'cognitive impairment,', 'rivastigmine'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury\n* Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)\n* Be required to have had sufficient education to read, write, and effectively communicate\n* Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement\n\nExclusion Criteria:\n\n* A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances\n* A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication\n* An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations\n* Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00171795', 'briefTitle': 'Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment', 'orgStudyIdInfo': {'id': 'CENA713BDE01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivastigmine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}