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NCT Number: NCT05446805

Depression and Driving

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Drive

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F 18 AV-1451 (Flortaucipir)

Drug

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).

Other names: AV-1451

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

Drug

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.

Other names: PIB

Primary outcomes

  1. Latitude via DRIVES chip

    Time frame: Daily for up to five years

    The latitude coordinate of the location of the vehicle being driven

  2. Longitude via DRIVES chip

    Time frame: Daily for up to five years

    The Longitude coordinate of the location of the vehicle being driven

  3. Vehicle Speed via DRIVES chip

    Time frame: Daily for up to five years

    The speed at which the vehicle being driven is moving.

  4. Speed Limit via DRIVES chip

    Time frame: Daily for up to five years

    The posted speed limit for the location that participant is driving.

  5. 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.

  6. Event Name via DRIVES Chip

    Time frame: Daily for up to five years

    Name of the geofence in which participant had a driving event.

  7. Address via DRIVES chip

    Time frame: Daily for up to five years

    Address of the location in which participant had a driving event.

  8. 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.

  9. Event Time via DRIVES chip

    Time frame: Daily for up to five years

    Timestamp in GMT on which the event occurred.

  10. Odometer Reading via DRIVES chip

    Time frame: Daily for up to five years

    Odometer reading of the vehicle.

  11. Trip Distance via DRIVES chip

    Time frame: Daily for up to five years

    Total distance covered during the trip

  12. Peak Speed via DRIVES chip

    Time frame: Daily for up to five years

    Highest speed attained by the vehicle during the trip.

  13. Average Speed

    Time frame: Daily for up to five years

    Average trip speed of the vehicle.

  14. Initial Speed via DRIVES chip

    Time frame: Daily for up to five years

    Speed at the beginning of the trip.

  15. Final Speed via DRIVES chip.

    Time frame: Daily for up to five years

    Speed at the end of the trip.

Secondary outcomes

  1. Trail Making A

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.

  2. Trail Making B

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.

  3. Montreal Cognitive Assessment (MoCA) Total

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.

  4. Category Fluency

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.

  5. Phonemic Fluency

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.

  6. Mini Mental Status Exam

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.

  7. Clinical Dementia Rating (CDR) Sum of Boxes

    Time frame: Annually for up to five years

    This will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment/dementia severity.

Other outcomes

  1. Plasma based biomarker

    Time frame: Each participant will complete a blood draw within their first year of participation.

    Analyses of amyloid and tau burden among plasma samples

  2. Cerebrospinal fluid biomarker

    Time frame: Each participant will complete an optional lumbar puncture within their first year of participation.

    Analyses of amyloid and tau burden among cerebrospinal fluid samples

  3. Amyloid PET-based biomarker

    Time frame: Each participant will complete a PET scan with radiotracer PIB within their first year of participation.

    Amyloid measured by Pittburgh compound B

  4. Tau PET-based biomarker

    Time frame: Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.

    Tau measured by AV1451

Study contacts

Contact information is provided by the study sponsor or research team.

Beau Ances, MD, PhD

CONTACT

[email protected]

(314) 747-8423

Kaylin Taylor, MA

CONTACT

[email protected]

314-273-3573

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)

Acronym: D&D

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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