Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT05446805

Conditions

Depression

Drive

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

F 18 AV-1451 (Flortaucipir)

[11C]-Pittsburgh Compound B ([11C]PiB)

Study Details

Brief summary:

This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).

Conditions

Depression

Drive

Study ID

NCT05446805

Start date

Jun 17, 2021

Status verified date

Jun, 2026

Completion date

Dec 17, 2027

Anticipated

Primary completion date

Jun 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

depression

All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.

control

All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.

Interventions

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).

[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 measure

  • Latitude via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Longitude via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Vehicle Speed via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Speed Limit via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Difference via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Event Name via DRIVES Chip [ Time Frame: Daily for up to five years ]
  • Address via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Event Type via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Event Time via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Odometer Reading via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Trip Distance via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Peak Speed via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Average Speed [ Time Frame: Daily for up to five years ]
  • Initial Speed via DRIVES chip [ Time Frame: Daily for up to five years ]
  • Final Speed via DRIVES chip. [ Time Frame: Daily for up to five years ]

Central Contacts and Locations

Central contacts

Kaylin Taylor, MA

314-273-3573kaylin.james@wustl.edu

Beau Ances, MD, PhD

(314) 747-8423bances@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kaylin Taylor, MA

314-273-3573msamantha@wustl.edu

Beau Ances, MD, PhD

(314)747-8423bances@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-08.