Depression and Driving (D&D)

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

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

Study Overview

• Status: Recruiting
• Conditions: Depression; Drive
• Intervention / Treatment: Drug: F 18 AV-1451 (Flortaucipir); Drug: [11C]-Pittsburgh Compound B ([11C]PiB)

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).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Kaylin Taylor, MA; Phone Number: 314-273-3573; Email: kaylin.james@wustl.edu
• Study Contact Backup: Name: Beau Ances, MD, PhD; Phone Number: (314) 747-8423; Email: bances@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Kaylin Taylor, MA; Phone Number: 314-273-3573; Email: msamantha@wustl.edu
      • Contact: Beau Ances, MD, PhD; Phone Number: (314)747-8423; Email: bances@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

70 participants will create a depressed cohort in which they must be determined to have active major depressive disorder (MDD) as defined by psychiatrist, Dr. Eric Lenze.

70 participants will be cognitively normal (CDR 0) or cognitively abnormal (CDR 0.5 or 1) but will be considered control cohort.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
depression; All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.	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).; Other Names: AV-1451; 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.; Other Names: PIB
control; All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.	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).; Other Names: AV-1451; 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.; Other Names: PIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latitude via DRIVES chip	The latitude coordinate of the location of the vehicle being driven	Daily for up to five years
Longitude via DRIVES chip	The Longitude coordinate of the location of the vehicle being driven	Daily for up to five years
Vehicle Speed via DRIVES chip	The speed at which the vehicle being driven is moving.	Daily for up to five years
Speed Limit via DRIVES chip	The posted speed limit for the location that participant is driving.	Daily for up to five years
Difference via DRIVES chip	The difference between the speed at which the vehicle is moving and the posted speed limit for the location.	Daily for up to five years
Event Name via DRIVES Chip	Name of the geofence in which participant had a driving event.	Daily for up to five years
Address via DRIVES chip	Address of the location in which participant had a driving event.	Daily for up to five years
Event Type via DRIVES chip	Enumeration describing the type of event: ignition on, heartbeat, ignition off, braking, acceleration, overspeeding, idling, low fuel, cornering, low battery event, diagnostic event triggered.	Daily for up to five years
Event Time via DRIVES chip	Timestamp in GMT on which the event occurred.	Daily for up to five years
Odometer Reading via DRIVES chip	Odometer reading of the vehicle.	Daily for up to five years
Trip Distance via DRIVES chip	Total distance covered during the trip	Daily for up to five years
Peak Speed via DRIVES chip	Highest speed attained by the vehicle during the trip.	Daily for up to five years
Average Speed	Average trip speed of the vehicle.	Daily for up to five years
Initial Speed via DRIVES chip	Speed at the beginning of the trip.	Daily for up to five years
Final Speed via DRIVES chip.	Speed at the end of the trip.	Daily for up to five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trail Making A	This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.	Annually for up to five years
Trail Making B	This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.	Annually for up to five years
Montreal Cognitive Assessment (MoCA) Total	This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.	Annually for up to five years
Category Fluency	This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.	Annually for up to five years
Phonemic Fluency	This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.	Annually for up to five years
Mini Mental Status Exam	This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.	Annually for up to five years
Clinical Dementia Rating (CDR) Sum of Boxes	This will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment/dementia severity.	Annually for up to five years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma based biomarker	Analyses of amyloid and tau burden among plasma samples	Each participant will complete a blood draw within their first year of participation.
Cerebrospinal fluid biomarker	Analyses of amyloid and tau burden among cerebrospinal fluid samples	Each participant will complete an optional lumbar puncture within their first year of participation.
Amyloid PET-based biomarker	Amyloid measured by Pittburgh compound B	Each participant will complete a PET scan with radiotracer PIB within their first year of participation.
Tau PET-based biomarker	Tau measured by AV1451	Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Beau Ances, MD, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Estimated): June 17, 2027
• Study Completion (Estimated): December 17, 2027

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Anti-Inflammatory Agents; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole
• Other Study ID Numbers: 202003209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No