DepressionD&DNCT05446805
Depression and Driving
An observational study of Depression and Drive, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Drive
- What is being tested?
- F 18 AV-1451 (Flortaucipir) and [11C]-Pittsburgh Compound B ([11C]PiB)
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 17 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Kaylin Taylor, MA, 314-273-3573, msamantha@wustl.edu
Beau Ances, MD, PhD, (314)747-8423, bances@wustl.edu
About this study
Official title: 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).
Read the 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).
- Conditions
- Depression, Drive
- Being tested
- F 18 AV-1451 (Flortaucipir), [11C]-Pittsburgh Compound B ([11C]PiB)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F 18 AV-1451 (Flortaucipir)Drug
Also called AV-1451
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)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| depression | All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. Receives: Drug: F 18 AV-1451 (Flortaucipir); Drug: [11C]-Pittsburgh Compound B ([11C]PiB) | |
| control | All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. Receives: Drug: F 18 AV-1451 (Flortaucipir); Drug: [11C]-Pittsburgh Compound B ([11C]PiB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latitude via DRIVES chip
The latitude coordinate of the location of the vehicle being driven
Measured: Daily for up to five years
Longitude via DRIVES chip
The Longitude coordinate of the location of the vehicle being driven
Measured: Daily for up to five years
Vehicle Speed via DRIVES chip
The speed at which the vehicle being driven is moving.
Measured: Daily for up to five years
Speed Limit via DRIVES chip
The posted speed limit for the location that participant is driving.
Measured: 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.
Measured: Daily for up to five years
Event Name via DRIVES Chip
Name of the geofence in which participant had a driving event.
Measured: Daily for up to five years
Address via DRIVES chip
Address of the location in which participant had a driving event.
Measured: 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.
Measured: Daily for up to five years
Event Time via DRIVES chip
Timestamp in GMT on which the event occurred.
Measured: Daily for up to five years
Odometer Reading via DRIVES chip
Odometer reading of the vehicle.
Measured: Daily for up to five years
Trip Distance via DRIVES chip
Total distance covered during the trip
Measured: Daily for up to five years
Peak Speed via DRIVES chip
Highest speed attained by the vehicle during the trip.
Measured: Daily for up to five years
Average Speed
Average trip speed of the vehicle.
Measured: Daily for up to five years
Initial Speed via DRIVES chip
Speed at the beginning of the trip.
Measured: Daily for up to five years
Final Speed via DRIVES chip.
Speed at the end of the trip.
Measured: Daily for up to five years
Secondary outcomes (7)
Trail Making A
This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Annually for up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start17 Jun 2021
- Primary completion17 Jun 2027 (estimated)
- Study completion17 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beau Ances, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446805
- Sponsor's protocol ID
- 202003209
- Acronym
- D&D
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)
- ClinicalTrials.gov ID
- NCT05446805
- Acronym / sponsor ID
- D&D / 202003209
- Conditions
- Depression, Drive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 17 Dec 2027 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depression | – | Drug: F 18 AV-1451 (Flortaucipir), Drug: [11C]-Pittsburgh Compound B ([11C]PiB)All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. |
| control | – | Drug: F 18 AV-1451 (Flortaucipir), Drug: [11C]-Pittsburgh Compound B ([11C]PiB)All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F 18 AV-1451 (Flortaucipir)Also: AV-1451A 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). | Drug | control, depression |
| [11C]-Pittsburgh Compound B ([11C]PiB)Also: PIBA 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. | Drug | control, depression |
Primary outcome
Latitude via DRIVES chip
Time frame: Daily for up to five years
The latitude coordinate of the location of the vehicle being driven
Longitude via DRIVES chip
Time frame: Daily for up to five years
The Longitude coordinate of the location of the vehicle being driven
Vehicle Speed via DRIVES chip
Time frame: Daily for up to five years
The speed at which the vehicle being driven is moving.
Speed Limit via DRIVES chip
Time frame: Daily for up to five years
The posted speed limit for the location that participant is driving.
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.
Event Name via DRIVES Chip
Time frame: Daily for up to five years
Name of the geofence in which participant had a driving event.
Address via DRIVES chip
Time frame: Daily for up to five years
Address of the location in which participant had a driving event.
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.
Event Time via DRIVES chip
Time frame: Daily for up to five years
Timestamp in GMT on which the event occurred.
Odometer Reading via DRIVES chip
Time frame: Daily for up to five years
Odometer reading of the vehicle.
Trip Distance via DRIVES chip
Time frame: Daily for up to five years
Total distance covered during the trip
Peak Speed via DRIVES chip
Time frame: Daily for up to five years
Highest speed attained by the vehicle during the trip.
Average Speed
Time frame: Daily for up to five years
Average trip speed of the vehicle.
Initial Speed via DRIVES chip
Time frame: Daily for up to five years
Speed at the beginning of the trip.
Final Speed via DRIVES chip.
Time frame: Daily for up to five years
Speed at the end of the trip.
7 secondary outcomes
Trail Making A
Time frame: Annually for up to five years
Trail Making B
Time frame: Annually for up to five years
Montreal Cognitive Assessment (MoCA) Total
Time frame: Annually for up to five years
Category Fluency
Time frame: Annually for up to five years
Phonemic Fluency
Time frame: Annually for up to five years
Mini Mental Status Exam
Time frame: Annually for up to five years
Clinical Dementia Rating (CDR) Sum of Boxes
Time frame: Annually for up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beau Ances, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Drive, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaylin Taylor, MA (314-273-3573, kaylin.james@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latitude via DRIVES chip (time frame: Daily for up to five years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.