Depression and Driving

NCT05446805 | Recruiting FDA Drug

• 1 other identifier: 202003209
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Drive

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (7)

• Trail Making A

  Annually for up to five years

• Trail Making B

  Annually for up to five years

• Montreal Cognitive Assessment (MoCA) Total

  Annually for up to five years

• Category Fluency

  Annually for up to five years

• Phonemic Fluency

  Annually for up to five years

Other Outcomes (4)

• Plasma based biomarker

  Each participant will complete a blood draw within their first year of participation.

• Cerebrospinal fluid biomarker

  Each participant will complete an optional lumbar puncture within their first year of participation.

• Amyloid PET-based biomarker

  Each participant will complete a PET scan with radiotracer PIB within their first year of participation.

Study Arms (2)

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); 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.

Drug: F 18 AV-1451 (Flortaucipir); Drug: [11C]-Pittsburgh Compound B ([11C]PiB)

Interventions

F 18 AV-1451 (Flortaucipir) DRUG

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).

Also known as: AV-1451

control; depression

[11C]-Pittsburgh Compound B ([11C]PiB) DRUG

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.

Also known as: PIB

control; depression

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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
• years or older
• Speaks English

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganesh Babulal: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ganesh Babulal, PhD, OTD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Murphy, MA

CONTACT

(314) 286-2435; msamantha@wustl.edu

Ganesh Babulal, PhD, OTD

CONTACT

(952) 334-8536; babulalg@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: July 7, 2022
• Study Start: June 17, 2021
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)