Depression and Driving

Depression Clinical Trial

— D&D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446805
• Other study ID #: 202003209
• Status: Recruiting
• Start date: June 17, 2021
• Est. completion date: December 17, 2026

Study information

• Verified date: July 2023
• Source: Washington University School of Medicine
• Contact: Samantha Murphy, MA
• Phone: (314) 286-2435
• Email: msamantha[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 17, 2026
• Est. primary completion date: June 17, 2026
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Drive

Intervention

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).
• [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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ganesh Babulal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	Tau PET-based biomarker	Tau measured by AV1451	Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.
Primary	Latitude via DRIVES chip	The latitude coordinate of the location of the vehicle being driven	Daily for up to five years
Primary	Longitude via DRIVES chip	The Longitude coordinate of the location of the vehicle being driven	Daily for up to five years
Primary	Vehicle Speed via DRIVES chip	The speed at which the vehicle being driven is moving.	Daily for up to five years
Primary	Speed Limit via DRIVES chip	The posted speed limit for the location that participant is driving.	Daily for up to five years
Primary	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
Primary	Event Name via DRIVES Chip	Name of the geofence in which participant had a driving event.	Daily for up to five years
Primary	Address via DRIVES chip	Address of the location in which participant had a driving event.	Daily for up to five years
Primary	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
Primary	Event Time via DRIVES chip	Timestamp in GMT on which the event occurred.	Daily for up to five years
Primary	Odometer Reading via DRIVES chip	Odometer reading of the vehicle.	Daily for up to five years
Primary	Trip Distance via DRIVES chip	Total distance covered during the trip	Daily for up to five years
Primary	Peak Speed via DRIVES chip	Highest speed attained by the vehicle during the trip.	Daily for up to five years
Primary	Average Speed	Average trip speed of the vehicle.	Daily for up to five years
Primary	Initial Speed via DRIVES chip	Speed at the beginning of the trip.	Daily for up to five years
Primary	Final Speed via DRIVES chip.	Speed at the end of the trip.	Daily for up to five years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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