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Recruiting NCT05446805

Depression and Driving

— Observational Depression Drive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F 18 AV-1451 (Flortaucipir), [11C]-Pittsburgh Compound B ([11C]PiB).
Who it may be relevant to
Registry conditions: Depression, Drive. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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
  • 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.

Primary outcome measures

  • Latitude via DRIVES chip [Time frame: Daily for up to five years]
  • Longitude via DRIVES chip [Time frame: Daily for up to five years]
  • Vehicle Speed via DRIVES chip [Time frame: Daily for up to five years]
  • Speed Limit via DRIVES chip [Time frame: Daily for up to five years]
  • Difference via DRIVES chip [Time frame: Daily for up to five years]
  • Event Name via DRIVES Chip [Time frame: Daily for up to five years]
  • Address via DRIVES chip [Time frame: Daily for up to five years]
  • Event Type via DRIVES chip [Time frame: Daily for up to five years]
  • Event Time via DRIVES chip [Time frame: Daily for up to five years]
  • Odometer Reading via DRIVES chip [Time frame: Daily for up to five years]
Secondary outcome measures (7)
  • Trail Making A [Time frame: Annually for up to five years]
  • Trail Making B [Time frame: Annually for up to five years]
  • Montreal Cognitive Assessment (MoCA) Total [Time frame: Annually for up to five years]
  • Category Fluency [Time frame: Annually for up to five years]
  • Phonemic Fluency [Time frame: Annually for up to five years]
  • Mini Mental Status Exam [Time frame: Annually for up to five years]
  • Clinical Dementia Rating (CDR) Sum of Boxes [Time frame: Annually for up to five 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT05446805 · 202003209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗