Depression and Driving

NCT ID: NCT05446805

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2026-12-17

Brief Summary

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).

Conditions

Depression; Drive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

depression

All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.

F 18 AV-1451 (Flortaucipir)

Intervention Type: 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).

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

Intervention Type: 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.

control

All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.

F 18 AV-1451 (Flortaucipir)

Intervention Type: 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).

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

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

AV-1451; PIB

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ganesh Babulal

OTHER

Sponsor Role: lead

Responsible Party

Ganesh Babulal

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ganesh Babulal, PhD, OTD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Murphy, MA

Role: CONTACT

msamantha@wustl.edu

(314) 286-2435

Ganesh Babulal, PhD, OTD

Role: CONTACT

babulalg@wustl.edu

(952) 334-8536

Facility Contacts

Samantha Murphy, MA

Role: primary

msamantha@wustl.edu

314-286-2435

Ganesh Babulal, PhD, OTD

Role: backup

babulalg@wustl.edu

(952) 334-8536

Other Identifiers

202003209

Identifier Type: -

Identifier Source: org_study_id