Recruiting
Depression and Driving
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
ClinicalTrials.gov IDNCT05446805
PhaseNot Applicable
Enrollment150
SponsorWashington University School of Medicine
Age65 Years
SexALL
Conditions studied
Depression, Drive
About this study
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 outcomes
- Latitude via DRIVES chip (Daily for up to five years)
- Longitude via DRIVES chip (Daily for up to five years)
- Vehicle Speed via DRIVES chip (Daily for up to five years)
- Speed Limit via DRIVES chip (Daily for up to five years)
- Difference via DRIVES chip (Daily for up to five years)
- Event Name via DRIVES Chip (Daily for up to five years)
- Address via DRIVES chip (Daily for up to five years)
- Event Type via DRIVES chip (Daily for up to five years)
Eligibility information
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
Study locations
- Washington University School of Medicine, St Louis, Missouri 63110 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.