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Идёт набор NCT05446805

Depression and Driving

— Наблюдательное Depression Drive

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: F 18 AV-1451 (Flortaucipir), [11C]-Pittsburgh Compound B ([11C]PiB).
Кому может быть актуально
Состояния в реестре: Depression, Drive. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

  • Препарат 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
  • Препарат [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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT05446805 · 202003209

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗