Anxiety & Depression Association of America

Depression and Driving

Purpose

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

Conditions

Depression
Drive

Eligibility

Eligible Ages: Over 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Ganesh Babulal

Study Contact

Samantha Murphy, MA
(314) 286-2435
msamantha@wustl.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.