Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 4:42 PM
Study NCT ID:
NCT01608256
Status:
UNKNOWN
Last Update Posted:
2012-05-31
First Post:
2012-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Driving Ability Among People With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-29', 'studyFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment', 'Automobile Driving', 'cognitive aspects'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.', 'detailedDescription': 'Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test.\n\nThe difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year.\n\nExclusion Criteria:\n\n* people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment"}, 'identificationModule': {'nctId': 'NCT01608256', 'acronym': 'MCI', 'briefTitle': 'Driving Ability Among People With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Assessing the Effect of MCI on Driving Ability by Using on Road Driving Test. The Relationship Between Their Driving Outcome and Their Cognitive Decline Will be Examined', 'orgStudyIdInfo': {'id': 'ק0012012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild cognitive impairment', 'description': "men and women, aged 50 to 70. The inclusion criteria are:diagnosis of MCI (given by a neurologist), valid driver's license and driving experience of at least a year. the exclusion criteria are: people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment."}, {'label': 'Healthy people', 'description': "Men and women, ages 50-70. the inclusion criteria are: healthy people with out neurological disease or psychiatric illness, have valid driver's license and driving experience of at least a year."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hedera', 'country': 'Israel', 'facility': 'Sherotw breot Clalit'}], 'centralContacts': [{'name': 'Areej Wishahi, B.A.', 'role': 'CONTACT', 'email': 'areej-joda@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student for the MA degree', 'investigatorFullName': 'Areej Wishahi', 'investigatorAffiliation': 'Tel Aviv University'}}}}