An observational study in Depression and Drive, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Washington University School of Medicine · Observational
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 150 is close to the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
70 participants will be cognitively normal (CDR 0) or cognitively abnormal (CDR 0.5 or 1) but will be considered control cohort.
Exclusion Criteria:
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
Drug: F 18 AV-1451 (Flortaucipir) · Drug: [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.
Drug: F 18 AV-1451 (Flortaucipir) · Drug: [11C]-Pittsburgh Compound B ([11C]PiB)
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).
Also known as: AV-1451
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.
Also known as: PIB
Latitude via DRIVES chip
The latitude coordinate of the location of the vehicle being driven
Time frame: Daily for up to five years
Longitude via DRIVES chip
The Longitude coordinate of the location of the vehicle being driven
Time frame: Daily for up to five years
Vehicle Speed via DRIVES chip
The speed at which the vehicle being driven is moving.
Time frame: Daily for up to five years
Speed Limit via DRIVES chip
The posted speed limit for the location that participant is driving.
Time frame: Daily for up to five years
Difference via DRIVES chip
The difference between the speed at which the vehicle is moving and the posted speed limit for the location.
Time frame: Daily for up to five years
Event Name via DRIVES Chip
Name of the geofence in which participant had a driving event.
Time frame: Daily for up to five years
Address via DRIVES chip
Address of the location in which participant had a driving event.
Time frame: Daily for up to five years
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.
Time frame: Daily for up to five years
Event Time via DRIVES chip
Timestamp in GMT on which the event occurred.
Time frame: Daily for up to five years
Odometer Reading via DRIVES chip
Odometer reading of the vehicle.
Time frame: Daily for up to five years
Trip Distance via DRIVES chip
Total distance covered during the trip
Time frame: Daily for up to five years
Peak Speed via DRIVES chip
Highest speed attained by the vehicle during the trip.
Time frame: Daily for up to five years
Average Speed
Average trip speed of the vehicle.
Time frame: Daily for up to five years
Initial Speed via DRIVES chip
Speed at the beginning of the trip.
Time frame: Daily for up to five years
Final Speed via DRIVES chip.
Speed at the end of the trip.
Time frame: Daily for up to five years
Trail Making A
This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Time frame: Annually for up to five years
Trail Making B
This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Time frame: Annually for up to five years
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.
Time frame: Annually for up to five years
Category Fluency
This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Time frame: Annually for up to five years
Phonemic Fluency
This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Time frame: Annually for up to five years
Mini Mental Status Exam
This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.
Time frame: Annually for up to five years
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/dementia severity.
Time frame: Annually for up to five years
Plasma based biomarker
Analyses of amyloid and tau burden among plasma samples
Time frame: Each participant will complete a blood draw within their first year of participation.
Cerebrospinal fluid biomarker
Analyses of amyloid and tau burden among cerebrospinal fluid samples
Time frame: Each participant will complete an optional lumbar puncture within their first year of participation.
Amyloid PET-based biomarker
Amyloid measured by Pittburgh compound B
Time frame: Each participant will complete a PET scan with radiotracer PIB within their first year of participation.
Tau PET-based biomarker
Tau measured by AV1451
Time frame: Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.
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