Depression and Driving

ConditionsDepression Drive

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65+

SponsorWashington University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).
[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.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: depression2 interventions

Group B: control2 interventions

Trial outcomes

Primary outcomes

Latitude via DRIVES chip

The latitude coordinate of the location of the vehicle being driven

Time frame

Daily for up to five years

Longitude via DRIVES chip

The Longitude coordinate of the location of the vehicle being driven

Time frame

Daily for up to five years

Vehicle Speed via DRIVES chip

The speed at which the vehicle being driven is moving.

Time frame

Daily for up to five years

Speed Limit via DRIVES chip

The posted speed limit for the location that participant is driving.

Time frame

Daily for up to five years

Secondary outcomes

Trail Making A

This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Annually for up to five years

Other outcomes

Plasma based biomarker

Analyses of amyloid and tau burden among plasma samples

Time frame

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

Cerebrospinal fluid biomarker

Analyses of amyloid and tau burden among cerebrospinal fluid samples

Time frame

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

Amyloid PET-based biomarker

Amyloid measured by Pittburgh compound B

Time frame

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

Tau PET-based biomarker

Tau measured by AV1451

Time frame

Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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