Clinical trial NCT05446805: Depression and Driving
Official title: The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Drive
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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).

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

Primary outcomes:
measure: Latitude via DRIVES chip
timeFrame: Daily for up to five years
measure: Longitude via DRIVES chip
timeFrame: Daily for up to five years
measure: Vehicle Speed via DRIVES chip
timeFrame: Daily for up to five years
measure: Speed Limit via DRIVES chip
timeFrame: Daily for up to five years
measure: Difference via DRIVES chip
timeFrame: Daily for up to five years
measure: Event Name via DRIVES Chip
timeFrame: Daily for up to five years
measure: Address via DRIVES chip
timeFrame: Daily for up to five years
measure: Event Type via DRIVES chip
timeFrame: Daily for up to five years
measure: Event Time via DRIVES chip
timeFrame: Daily for up to five years
measure: Odometer Reading via DRIVES chip
timeFrame: Daily for up to five years
measure: Trip Distance via DRIVES chip
timeFrame: Daily for up to five years
measure: Peak Speed via DRIVES chip
timeFrame: Daily for up to five years
measure: Average Speed
timeFrame: Daily for up to five years
measure: Initial Speed via DRIVES chip
timeFrame: Daily for up to five years
measure: Final Speed via DRIVES chip.
timeFrame: Daily for up to five years
Secondary outcomes:
measure: Trail Making A
timeFrame: Annually for up to five years
measure: Trail Making B
timeFrame: Annually for up to five years
measure: Montreal Cognitive Assessment (MoCA) Total
timeFrame: Annually for up to five years
measure: Category Fluency
timeFrame: Annually for up to five years
measure: Phonemic Fluency
timeFrame: Annually for up to five years
measure: Mini Mental Status Exam
timeFrame: Annually for up to five years
measure: Clinical Dementia Rating (CDR) Sum of Boxes
timeFrame: Annually for up to five years
Other outcomes:
measure: Plasma based biomarker
timeFrame: Each participant will complete a blood draw within their first year of participation.
measure: Cerebrospinal fluid biomarker
timeFrame: Each participant will complete an optional lumbar puncture within their first year of participation.
measure: Amyloid PET-based biomarker
timeFrame: Each participant will complete a PET scan with radiotracer PIB within their first year of participation.
measure: Tau PET-based biomarker
timeFrame: Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ganesh Babulal, PhD, OTD
role: PRINCIPAL_INVESTIGATOR
References: