Depression and Driving (D&D)

June 4, 2026 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Latitude via DRIVES chip
Time Frame: Daily for up to five years
The latitude coordinate of the location of the vehicle being driven
Daily for up to five years
Longitude via DRIVES chip
Time Frame: Daily for up to five years
The Longitude coordinate of the location of the vehicle being driven
Daily for up to five years
Vehicle Speed via DRIVES chip
Time Frame: Daily for up to five years
The speed at which the vehicle being driven is moving.
Daily for up to five years
Speed Limit via DRIVES chip
Time Frame: Daily for up to five years
The posted speed limit for the location that participant is driving.
Daily for up to five years
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.
Daily for up to five years
Event Name via DRIVES Chip
Time Frame: Daily for up to five years
Name of the geofence in which participant had a driving event.
Daily for up to five years
Address via DRIVES chip
Time Frame: Daily for up to five years
Address of the location in which participant had a driving event.
Daily for up to five years
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.
Daily for up to five years
Event Time via DRIVES chip
Time Frame: Daily for up to five years
Timestamp in GMT on which the event occurred.
Daily for up to five years
Odometer Reading via DRIVES chip
Time Frame: Daily for up to five years
Odometer reading of the vehicle.
Daily for up to five years
Trip Distance via DRIVES chip
Time Frame: Daily for up to five years
Total distance covered during the trip
Daily for up to five years
Peak Speed via DRIVES chip
Time Frame: Daily for up to five years
Highest speed attained by the vehicle during the trip.
Daily for up to five years
Average Speed
Time Frame: Daily for up to five years
Average trip speed of the vehicle.
Daily for up to five years
Initial Speed via DRIVES chip
Time Frame: Daily for up to five years
Speed at the beginning of the trip.
Daily for up to five years
Final Speed via DRIVES chip.
Time Frame: Daily for up to five years
Speed at the end of the trip.
Daily for up to five years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Annually for up to five years
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.
Annually for up to five years
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.
Annually for up to five years
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.
Annually for up to five years
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.
Annually for up to five years
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.
Annually for up to five years
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.
Annually for up to five years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Each participant will complete a blood draw within their first year of participation.
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
Each participant will complete an optional lumbar puncture within their first year of participation.
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
Each participant will complete a PET scan with radiotracer PIB within their first year of participation.
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
Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beau Ances, MD, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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