The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Initial Speed via DRIVES chip
研究概览
简要总结
This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
depression
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
干预措施: F 18 AV-1451 (Flortaucipir) (Drug)
depression
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
干预措施: [11C]-Pittsburgh Compound B ([11C]PiB) (Drug)
control
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
干预措施: F 18 AV-1451 (Flortaucipir) (Drug)
control
All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.
干预措施: [11C]-Pittsburgh Compound B ([11C]PiB) (Drug)
结局指标
主要结局
Initial Speed via DRIVES chip
时间窗: Daily for up to five years
Speed at the beginning of the trip.
Event Type via DRIVES chip
时间窗: Daily for up to five years
Enumeration describing the type of event: ignition on, heartbeat, ignition off, braking, acceleration, overspeeding, idling, low fuel, cornering, low battery event, diagnostic event triggered.
Event Name via DRIVES Chip
时间窗: Daily for up to five years
Name of the geofence in which participant had a driving event.
Event Time via DRIVES chip
时间窗: Daily for up to five years
Timestamp in GMT on which the event occurred.
Trip Distance via DRIVES chip
时间窗: Daily for up to five years
Total distance covered during the trip
Longitude via DRIVES chip
时间窗: Daily for up to five years
The Longitude coordinate of the location of the vehicle being driven
Speed Limit via DRIVES chip
时间窗: Daily for up to five years
The posted speed limit for the location that participant is driving.
Latitude via DRIVES chip
时间窗: Daily for up to five years
The latitude coordinate of the location of the vehicle being driven
Average Speed
时间窗: Daily for up to five years
Average trip speed of the vehicle.
Final Speed via DRIVES chip.
时间窗: Daily for up to five years
Speed at the end of the trip.
Vehicle Speed via DRIVES chip
时间窗: Daily for up to five years
The speed at which the vehicle being driven is moving.
Difference via DRIVES chip
时间窗: Daily for up to five years
The difference between the speed at which the vehicle is moving and the posted speed limit for the location.
Odometer Reading via DRIVES chip
时间窗: Daily for up to five years
Odometer reading of the vehicle.
Address via DRIVES chip
时间窗: Daily for up to five years
Address of the location in which participant had a driving event.
Peak Speed via DRIVES chip
时间窗: Daily for up to five years
Highest speed attained by the vehicle during the trip.
次要结局
- Montreal Cognitive Assessment (MoCA) Total(Annually for up to five years)
- Trail Making B(Annually for up to five years)
- Phonemic Fluency(Annually for up to five years)
- Mini Mental Status Exam(Annually for up to five years)
- Trail Making A(Annually for up to five years)
- Category Fluency(Annually for up to five years)
- Clinical Dementia Rating (CDR) Sum of Boxes(Annually for up to five years)
研究者
Ganesh Babulal
Associate Professor
Washington University School of Medicine