Depression and Driving
- Conditions
- DepressionDrive
- Interventions
- Drug: [11C]-Pittsburgh Compound B ([11C]PiB)
- Registration Number
- NCT05446805
- Lead Sponsor
- Ganesh Babulal
- Brief Summary
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Drive on average at least once per week
- Has a valid driver's license
- Willing to complete blood draw
- Willing to complete either lumbar puncture or PET imaging
- 65 years or older
- Speaks English
- Not willing to complete blood draw and/or one other biomarker
- Less than 65 years of age
- Does not drive a vehicle/ is no longer actively driving
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description depression F 18 AV-1451 (Flortaucipir) All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. control F 18 AV-1451 (Flortaucipir) All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. depression [11C]-Pittsburgh Compound B ([11C]PiB) All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. control [11C]-Pittsburgh Compound B ([11C]PiB) All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
- Primary Outcome Measures
Name Time Method Initial Speed via DRIVES chip Daily for up to five years Speed at the beginning of the trip.
Event Type via DRIVES chip Daily for up to five years Enumeration describing the type of event: ignition on, heartbeat, ignition off, braking, acceleration, overspeeding, idling, low fuel, cornering, low battery event, diagnostic event triggered.
Event Name via DRIVES Chip Daily for up to five years Name of the geofence in which participant had a driving event.
Event Time via DRIVES chip Daily for up to five years Timestamp in GMT on which the event occurred.
Trip Distance via DRIVES chip Daily for up to five years Total distance covered during the trip
Longitude via DRIVES chip Daily for up to five years The Longitude coordinate of the location of the vehicle being driven
Speed Limit via DRIVES chip Daily for up to five years The posted speed limit for the location that participant is driving.
Latitude via DRIVES chip Daily for up to five years The latitude coordinate of the location of the vehicle being driven
Average Speed Daily for up to five years Average trip speed of the vehicle.
Final Speed via DRIVES chip. Daily for up to five years Speed at the end of the trip.
Vehicle Speed via DRIVES chip Daily for up to five years The speed at which the vehicle being driven is moving.
Difference via DRIVES chip Daily for up to five years The difference between the speed at which the vehicle is moving and the posted speed limit for the location.
Odometer Reading via DRIVES chip Daily for up to five years Odometer reading of the vehicle.
Address via DRIVES chip Daily for up to five years Address of the location in which participant had a driving event.
Peak Speed via DRIVES chip Daily for up to five years Highest speed attained by the vehicle during the trip.
- Secondary Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA) Total Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.
Trail Making B Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Phonemic Fluency Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Mini Mental Status Exam Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.
Trail Making A Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Category Fluency Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Clinical Dementia Rating (CDR) Sum of Boxes Annually for up to five years This will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment/dementia severity.
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States