The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ganesh Babulal
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Initial Speed via DRIVES chip
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
depression
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
Intervention: F 18 AV-1451 (Flortaucipir) (Drug)
depression
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
Intervention: [11C]-Pittsburgh Compound B ([11C]PiB) (Drug)
control
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
Intervention: F 18 AV-1451 (Flortaucipir) (Drug)
control
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
Intervention: [11C]-Pittsburgh Compound B ([11C]PiB) (Drug)
Outcomes
Primary Outcomes
Initial Speed via DRIVES chip
Time Frame: Daily for up to five years
Speed at the beginning of the trip.
Event Type via DRIVES chip
Time Frame: 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
Time Frame: Daily for up to five years
Name of the geofence in which participant had a driving event.
Event Time via DRIVES chip
Time Frame: Daily for up to five years
Timestamp in GMT on which the event occurred.
Trip Distance via DRIVES chip
Time Frame: Daily for up to five years
Total distance covered during the trip
Longitude via DRIVES chip
Time Frame: Daily for up to five years
The Longitude coordinate of the location of the vehicle being driven
Speed Limit via DRIVES chip
Time Frame: Daily for up to five years
The posted speed limit for the location that participant is driving.
Latitude via DRIVES chip
Time Frame: Daily for up to five years
The latitude coordinate of the location of the vehicle being driven
Average Speed
Time Frame: Daily for up to five years
Average trip speed of the vehicle.
Final Speed via DRIVES chip.
Time Frame: Daily for up to five years
Speed at the end of the trip.
Vehicle Speed via DRIVES chip
Time Frame: Daily for up to five years
The speed at which the vehicle being driven is moving.
Difference via DRIVES chip
Time Frame: 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
Time Frame: Daily for up to five years
Odometer reading of the vehicle.
Address via DRIVES chip
Time Frame: Daily for up to five years
Address of the location in which participant had a driving event.
Peak Speed via DRIVES chip
Time Frame: Daily for up to five years
Highest speed attained by the vehicle during the trip.
Secondary Outcomes
- Montreal Cognitive Assessment (MoCA) Total(Annually for up to five years)
- Trail Making B(Annually for up to five years)
- Phonemic Fluency(Annually for up to five years)
- Mini Mental Status Exam(Annually for up to five years)
- Trail Making A(Annually for up to five years)
- Category Fluency(Annually for up to five years)
- Clinical Dementia Rating (CDR) Sum of Boxes(Annually for up to five years)
Investigators
Ganesh Babulal
Associate Professor
Washington University School of Medicine