Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
placebo	Placebo (cornstarch)	placebo (cornstarch), capsule, once daily for 14 days
donepezil	donepezil	donepezil, capsule, 5mg daily once daily for 14 days

Primary Outcome Measures

Name	Time	Method
Speed Deviation	Day 15	A measure of deviation from posted speed limit, measured in km/h
Psychomotor Vigilance Test (PVT)	Day 15	A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Attention Network Test (ANT)	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
Deviation From Road Position	Day 15	A measure of deviation from central road position, measured in cm
Reaction Time to Wind Gusts	Day 15	Reaction time to wind gusts, measured in seconds
Percentage of Time in Safe Zone	Day 15	Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %
Collisions	Day 15	Number of collisions (on driving simulator)