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Depression and Driving

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05446805
Acronym
D&D
Enrollment
150
Registered
2022-07-07
Start date
2021-06-17
Completion date
2027-12-17
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Drive

Brief summary

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

Detailed description

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).

Interventions

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).

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Latitude via DRIVES chipDaily for up to five yearsThe latitude coordinate of the location of the vehicle being driven
Longitude via DRIVES chipDaily for up to five yearsThe Longitude coordinate of the location of the vehicle being driven
Vehicle Speed via DRIVES chipDaily for up to five yearsThe speed at which the vehicle being driven is moving.
Speed Limit via DRIVES chipDaily for up to five yearsThe posted speed limit for the location that participant is driving.
Difference via DRIVES chipDaily for up to five yearsThe difference between the speed at which the vehicle is moving and the posted speed limit for the location.
Event Name via DRIVES ChipDaily for up to five yearsName of the geofence in which participant had a driving event.
Address via DRIVES chipDaily for up to five yearsAddress of the location in which participant had a driving event.
Event Type via DRIVES chipDaily for up to five yearsEnumeration 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 chipDaily for up to five yearsTimestamp in GMT on which the event occurred.
Odometer Reading via DRIVES chipDaily for up to five yearsOdometer reading of the vehicle.
Trip Distance via DRIVES chipDaily for up to five yearsTotal distance covered during the trip
Peak Speed via DRIVES chipDaily for up to five yearsHighest speed attained by the vehicle during the trip.
Average SpeedDaily for up to five yearsAverage trip speed of the vehicle.
Initial Speed via DRIVES chipDaily for up to five yearsSpeed at the beginning of the trip.
Final Speed via DRIVES chip.Daily for up to five yearsSpeed at the end of the trip.

Secondary

MeasureTime frameDescription
Trail Making AAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Trail Making BAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Montreal Cognitive Assessment (MoCA) TotalAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.
Category FluencyAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Phonemic FluencyAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will test language ability.
Mini Mental Status ExamAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.
Clinical Dementia Rating (CDR) Sum of BoxesAnnually for up to five yearsThis will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment/dementia severity.

Countries

United States

Contacts

CONTACTKaylin Taylor, MA
kaylin.james@wustl.edu314-273-3573
CONTACTBeau Ances, MD, PhD
bances@wustl.edu(314) 747-8423
PRINCIPAL_INVESTIGATORBeau Ances, MD, PhD

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026