Geriatrics, Mental Health
Conditions
Keywords
Donepezil, Driving, Cholinesterase Inhibitors, Geriatric Psychiatry, Psychopharmacology, Aricept
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.
Interventions
DRUGdonepezil
Sponsors
University of Toronto
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Speed Deviation | Day 15 | A measure of deviation from posted speed limit, measured in km/h |
| 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) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Donepezil donepezil: donepezil 5mg, once daily for 2 weeks | 10 |
| Placebo Placebo (cornstarch): 1 capsule daily for 2 weeks | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Donepezil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 5.6 | 70.8 years STANDARD_DEVIATION 4.7 | 71.7 years STANDARD_DEVIATION 5.1 |
| Mini-Mental State Examination (MMSE) | 29.30 units on a scale STANDARD_DEVIATION 1.1 | 29.50 units on a scale STANDARD_DEVIATION 0.7 | 29.4 units on a scale STANDARD_DEVIATION 0.9 |
| number of driving days/week | 6.55 days STANDARD_DEVIATION 1 | 5.80 days STANDARD_DEVIATION 1.6 | 6.18 days STANDARD_DEVIATION 1.35 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 7 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Attention Network Test (ANT) | 672.37 milliseconds | Standard Deviation 70.9 |
| Placebo | Attention Network Test (ANT) | 637.58 milliseconds | Standard Deviation 68.7 |
Primary
Collisions
Number of collisions (on driving simulator)
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Collisions | 0.40 collisions | Standard Deviation 0.7 |
| Placebo | Collisions | 0.30 collisions | Standard Deviation 0.5 |
Primary
Deviation From Road Position
A measure of deviation from central road position, measured in cm
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Deviation From Road Position | 27.54 centimeters | Standard Deviation 1.1 |
| Placebo | Deviation From Road Position | 26.06 centimeters | Standard Deviation 1.7 |
Primary
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 %
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Percentage of Time in Safe Zone | 60.95 percentage of time | Standard Deviation 21.4 |
| Placebo | Percentage of Time in Safe Zone | 74.79 percentage of time | Standard Deviation 17.6 |
Primary
Psychomotor Vigilance Test (PVT)
A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Psychomotor Vigilance Test (PVT) | 302.62 milliseconds | Standard Deviation 53 |
| Placebo | Psychomotor Vigilance Test (PVT) | 277.13 milliseconds | Standard Deviation 23.9 |
Primary
Reaction Time to Wind Gusts
Reaction time to wind gusts, measured in seconds
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Reaction Time to Wind Gusts | 1.69 seconds | Standard Deviation 0.5 |
| Placebo | Reaction Time to Wind Gusts | 1.18 seconds | Standard Deviation 0.3 |
Primary
Speed Deviation
A measure of deviation from posted speed limit, measured in km/h
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Speed Deviation | -1.09 kilometers / hour | Standard Deviation 6.6 |
| Placebo | Speed Deviation | -2.41 kilometers / hour | Standard Deviation 4.8 |