[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473585":3},{"organization":4,"outcomesModule":7,"designInfo":92,"detailedDescription":96,"studyPopulation":97,"armGroups":98,"interventions":108,"overallOfficials":122,"centralContacts":126,"locations":135,"responsibleParty":154,"collaborators":93,"id":156,"slug":93,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":93,"enrollmentInfo":165,"targetDuration":93,"studyType":168,"phases":93,"briefSummary":169,"conditions":170,"keywords":93,"overallStatus":137,"whyStopped":93,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":55,"otherOutcomes":75},[9,13,16,19,22,25,28,31,34,37,40,43,46,49,52],{"measure":10,"description":11,"timeFrame":12},"Latitude via DRIVES chip","The latitude coordinate of the location of the vehicle being driven","Daily for up to five years",{"measure":14,"description":15,"timeFrame":12},"Longitude via DRIVES chip","The Longitude coordinate of the location of the vehicle being driven",{"measure":17,"description":18,"timeFrame":12},"Vehicle Speed via DRIVES chip","The speed at which the vehicle being driven is moving.",{"measure":20,"description":21,"timeFrame":12},"Speed Limit via DRIVES chip","The posted speed limit for the location that participant is driving.",{"measure":23,"description":24,"timeFrame":12},"Difference via DRIVES chip","The difference between the speed at which the vehicle is moving and the posted speed limit for the location.",{"measure":26,"description":27,"timeFrame":12},"Event Name via DRIVES Chip","Name of the geofence in which participant had a driving event.",{"measure":29,"description":30,"timeFrame":12},"Address via DRIVES chip","Address of the location in which participant had a driving event.",{"measure":32,"description":33,"timeFrame":12},"Event Type via DRIVES chip","Enumeration describing the type of event: ignition on, heartbeat, ignition off, braking, acceleration, overspeeding, idling, low fuel, cornering, low battery event, diagnostic event triggered.",{"measure":35,"description":36,"timeFrame":12},"Event Time via DRIVES chip","Timestamp in GMT on which the event occurred.",{"measure":38,"description":39,"timeFrame":12},"Odometer Reading via DRIVES chip","Odometer reading of the vehicle.",{"measure":41,"description":42,"timeFrame":12},"Trip Distance via DRIVES chip","Total distance covered during the trip",{"measure":44,"description":45,"timeFrame":12},"Peak Speed via DRIVES chip","Highest speed attained by the vehicle during the trip.",{"measure":47,"description":48,"timeFrame":12},"Average Speed","Average trip speed of the vehicle.",{"measure":50,"description":51,"timeFrame":12},"Initial Speed via DRIVES chip","Speed at the beginning of the trip.",{"measure":53,"description":54,"timeFrame":12},"Final Speed via DRIVES chip.","Speed at the end of the trip.",[56,60,62,65,68,70,72],{"measure":57,"description":58,"timeFrame":59},"Trail Making A","This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.","Annually for up to five years",{"measure":61,"description":58,"timeFrame":59},"Trail Making B",{"measure":63,"description":64,"timeFrame":59},"Montreal Cognitive Assessment (MoCA) Total","This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.",{"measure":66,"description":67,"timeFrame":59},"Category Fluency","This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.",{"measure":69,"description":67,"timeFrame":59},"Phonemic Fluency",{"measure":71,"description":64,"timeFrame":59},"Mini Mental Status Exam",{"measure":73,"description":74,"timeFrame":59},"Clinical Dementia Rating (CDR) Sum of Boxes","This will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment\u002Fdementia severity.",[76,80,84,88],{"measure":77,"description":78,"timeFrame":79},"Plasma based biomarker","Analyses of amyloid and tau burden among plasma samples","Each participant will complete a blood draw within their first year of participation.",{"measure":81,"description":82,"timeFrame":83},"Cerebrospinal fluid biomarker","Analyses of amyloid and tau burden among cerebrospinal fluid samples","Each participant will complete an optional lumbar puncture within their first year of participation.",{"measure":85,"description":86,"timeFrame":87},"Amyloid PET-based biomarker","Amyloid measured by Pittburgh compound B","Each participant will complete a PET scan with radiotracer PIB within their first year of participation.",{"measure":89,"description":90,"timeFrame":91},"Tau PET-based biomarker","Tau measured by AV1451","Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.",{"allocation":93,"interventionModel":93,"interventionModelDescription":93,"primaryPurpose":93,"observationalModel":94,"timePerspective":95,"maskingInfo":93},null,"COHORT","PROSPECTIVE","The long-term goal is to accurately identify who is at risk of decline in driving, to forecast when decline will occur, and to intervene before decline, thereby reducing the numbers of crashes, injuries, and death in older adults. The findings indicate that the long preclinical stage of Alzheimer disease (AD), as reflected in amyloid imaging and cerebrospinal fluid (CSF) biomarkers among cognitively normal participants, is associated with poorer driving performance on a standardized road test. This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).","70 participants will create a depressed cohort in which they must be determined to have active major depressive disorder (MDD) as defined by psychiatrist, Dr. Eric Lenze.\n\n70 participants will be cognitively normal (CDR 0) or cognitively abnormal (CDR 0.5 or 1) but will be considered control cohort.",[99,105],{"label":100,"type":93,"description":101,"interventionNames":102},"depression","All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.",[103,104],"Drug: F 18 AV-1451 (Flortaucipir)","Drug: [11C]-Pittsburgh Compound B ([11C]PiB)",{"label":106,"type":93,"description":101,"interventionNames":107},"control",[103,104],[109,116],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"DRUG","F 18 AV-1451 (Flortaucipir)","A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for \\[18F\\] AV-1451. A PET-certified medical professional will prepare and administer the \\[18F\\] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of \\[18F\\] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).",[106,100],[115],"AV-1451",{"type":110,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"[11C]-Pittsburgh Compound B ([11C]PiB)","A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for \\[11C\\] PIB. A PET-certified medical professional will prepare and administer the \\[11C\\] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of \\[11C\\] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.",[106,100],[121],"PIB",[123],{"name":124,"affiliation":5,"role":125},"Beau Ances, MD, PhD","PRINCIPAL_INVESTIGATOR",[127,132],{"name":128,"role":129,"phone":130,"phoneExt":93,"email":131},"Kaylin Taylor, MA","CONTACT","314-273-3573","kaylin.james@wustl.edu",{"name":124,"role":129,"phone":133,"phoneExt":93,"email":134},"(314) 747-8423","bances@wustl.edu",[136],{"facility":5,"status":137,"city":138,"state":139,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":148,"contacts":149},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":144,"coordinates":145},"Point",[146,147],-90.19789,38.62727,{"lat":147,"lon":146},[150,152],{"name":128,"role":129,"phone":130,"phoneExt":93,"email":151},"msamantha@wustl.edu",{"name":124,"role":129,"phone":153,"phoneExt":93,"email":134},"(314)747-8423",{"type":155,"investigatorFullName":93,"investigatorTitle":93,"investigatorAffiliation":93,"oldNameTitle":93,"oldOrganization":93},"SPONSOR","100473585",false,"NCT05446805","Depression and Driving","The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)","D&D","Inclusion Criteria:\n\n* Drive on average at least once per week\n* Has a valid driver's license\n* Willing to complete blood draw\n* Willing to complete either lumbar puncture or PET imaging\n* 65 years or older\n* Speaks English\n\nExclusion Criteria:\n\n* Not willing to complete blood draw and\u002For one other biomarker\n* Less than 65 years of age\n* Does not drive a vehicle\u002F is no longer actively driving","ALL","65 Years",{"count":166,"type":167},150,"ESTIMATED","OBSERVATIONAL","This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).",[171,172],"Depression","Drive","2026-06-04",{"date":175,"type":176},"2026-06-08","ACTUAL",{"date":178,"type":176},"2021-06-17",{"date":180,"type":167},"2027-12-17",{"name":5,"class":6},1]