NCT05446805 · Washington University School of Medicine
Depression and Driving
(D&D)
What this study is about
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
View original scientific description
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
Interventions
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).
DRUG
[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.
Primary outcome measures
Latitude via DRIVES chip
Time frame: Daily for up to five years
The latitude coordinate of the location of the vehicle being driven
Longitude via DRIVES chip
Time frame: Daily for up to five years
The Longitude coordinate of the location of the vehicle being driven
Vehicle Speed via DRIVES chip
Time frame: Daily for up to five years
The speed at which the vehicle being driven is moving.
Speed Limit via DRIVES chip
Time frame: Daily for up to five years
The posted speed limit for the location that participant is driving.
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.
Event Name via DRIVES Chip
Time frame: Daily for up to five years
Name of the geofence in which participant had a driving event.
Address via DRIVES chip
Time frame: Daily for up to five years
Address of the location in which participant had a driving event.
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 Time via DRIVES chip
Time frame: Daily for up to five years
Timestamp in GMT on which the event occurred.
Odometer Reading via DRIVES chip
Time frame: Daily for up to five years
Odometer reading of the vehicle.
Trip Distance via DRIVES chip
Time frame: Daily for up to five years
Total distance covered during the trip
Peak Speed via DRIVES chip
Time frame: Daily for up to five years
Highest speed attained by the vehicle during the trip.
Average Speed
Time frame: Daily for up to five years
Average trip speed of the vehicle.
Initial Speed via DRIVES chip
Time frame: Daily for up to five years
Speed at the beginning of the trip.
Final Speed via DRIVES chip.
Time frame: Daily for up to five years
Speed at the end of the trip.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations