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Completed

NCT Number: NCT00482001

Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.

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Key information

Conditions

Mental Health Behavior Geriatrics Personal Satisfaction Psychological Well-Being

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lakehead University, Thunder Bay, Ontario, Canada

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About this study

Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that are used to treat people with AD may impact on their driving abilities. Donepezil is a drug used to treat the memory problems associated with AD. While previous studies have shown that it slows the decline of activities of daily living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to perform on computerized flight simulators, no studies have examined the impact of donepezil on driving abilities in older adults.

The present investigation is a pilot study aiming to determine if donepezil helps healthy older drivers perform on driving simulators. Two Canadian academic centers have different driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or identical placebo for two weeks.

Using the driving simulator, we will assess various aspects of driving ability. These measures of driving performance will be compared between those who received the drug and those who received the placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • valid Ontario driver's license
  • active driver (greater than or equal to three times per week)
  • written, informed consent
  • lives in Toronto/Thunder Bay
  • healthy
  • Male between 65-75 years old

Exclusion criteria

  • cognitive impairment
  • psychiatric history
  • sleep disorder history
  • substance abuse
  • neurological history
  • medical illness
  • ophthalmological disease
  • psychoactive medications
  • contra-indications to Donepezil
  • experience car/motion sickness

Treatment and study plan

Donepezil

Drug

Other names: Aricept

Placebo (cornstarch)

Drug

Primary outcomes

  1. Psychomotor Vigilance Test (PVT)

    Time frame: Day 15

    A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus

  2. Attention Network Test (ANT)

    Time frame: Day 15

    A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus

  3. Speed Deviation

    Time frame: Day 15

    A measure of deviation from posted speed limit, measured in km/h

  4. Deviation From Road Position

    Time frame: Day 15

    A measure of deviation from central road position, measured in cm

  5. Reaction Time to Wind Gusts

    Time frame: Day 15

    Reaction time to wind gusts, measured in seconds

  6. Percentage of Time in Safe Zone

    Time frame: Day 15

    Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %

  7. Collisions

    Time frame: Day 15

    Number of collisions (on driving simulator)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • University of Toronto

Registry information

Official study title

The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2007
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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