Title

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

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    donepezil ...
  • Study Participants

    22
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.
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.
Study Started
Jun 30
2007
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Results Posted
May 10
2019
Last Update
May 10
2019

Drug donepezil

  • Other names: Aricept

Drug Placebo (cornstarch)

donepezil Experimental

donepezil, capsule, 5mg daily once daily for 14 days

placebo Placebo Comparator

placebo (cornstarch), capsule, once daily for 14 days

Criteria

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

Summary

Donepezil

Placebo

All Events

Event Type Organ System Event Term Donepezil Placebo

Psychomotor Vigilance Test (PVT)

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

Donepezil

302.62
milliseconds (Mean)
Standard Deviation: 53.0

Placebo

277.13
milliseconds (Mean)
Standard Deviation: 23.9

Attention Network Test (ANT)

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

Donepezil

672.37
milliseconds (Mean)
Standard Deviation: 70.9

Placebo

637.58
milliseconds (Mean)
Standard Deviation: 68.7

Speed Deviation

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

Donepezil

-1.09
kilometers / hour (Mean)
Standard Deviation: 6.6

Placebo

-2.41
kilometers / hour (Mean)
Standard Deviation: 4.8

Deviation From Road Position

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

Donepezil

27.54
centimeters (Mean)
Standard Deviation: 1.1

Placebo

26.06
centimeters (Mean)
Standard Deviation: 1.7

Reaction Time to Wind Gusts

Reaction time to wind gusts, measured in seconds

Donepezil

1.69
seconds (Mean)
Standard Deviation: 0.5

Placebo

1.18
seconds (Mean)
Standard Deviation: 0.3

Percentage of Time in Safe Zone

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

Donepezil

60.95
percentage of time (Mean)
Standard Deviation: 21.4

Placebo

74.79
percentage of time (Mean)
Standard Deviation: 17.6

Collisions

Number of collisions (on driving simulator)

Donepezil

0.4
collisions (Mean)
Standard Deviation: 0.7

Placebo

0.3
collisions (Mean)
Standard Deviation: 0.5

Total

20
Participants

Age, Continuous

71.7
years (Mean)
Standard Deviation: 5.1

Mini-Mental State Examination (MMSE)

29.4
units on a scale (Mean)
Standard Deviation: 0.9

number of driving days/week

6.18
days (Mean)
Standard Deviation: 1.35

Race and Ethnicity Not Collected

0
Participants

Region of Enrollment

Sex: Female, Male

Overall Study

Donepezil

Placebo

Drop/Withdrawal Reasons

Donepezil

Placebo