Depression and Driving

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

Detailed Description
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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).

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

Conditions
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Depression, Drive

Intervention / Treatment
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* Drug: F 18 AV-1451 (Flortaucipir)
* Drug: [11C]-Pittsburgh Compound B ([11C]PiB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| depression<br>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)<br>* 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).<br>* Other names: AV-1451;Drug: [11C]-Pittsburgh Compound B ([11C]PiB)<br>* 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.<br>* Other names: PIB;|
| control<br>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)<br>* 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).<br>* Other names: AV-1451;Drug: [11C]-Pittsburgh Compound B ([11C]PiB)<br>* 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.<br>* Other names: PIB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |