Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mental Health, Geriatrics

Intervention / Treatment
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* Drug: donepezil
* Drug: Placebo (cornstarch)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: donepezil<br>donepezil, capsule, 5mg daily once daily for 14 days | Drug: donepezil<br> <br> * Other names: Aricept;|
| Placebo Comparator: placebo<br>placebo (cornstarch), capsule, once daily for 14 days | Drug: Placebo (cornstarch)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor Vigilance Test (PVT) | A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus | Day 15 | 
| 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 | Day 15 | 
| Speed Deviation | A measure of deviation from posted speed limit, measured in km/h | Day 15 | 
| Deviation From Road Position | A measure of deviation from central road position, measured in cm | Day 15 | 
| Reaction Time to Wind Gusts | Reaction time to wind gusts, measured in seconds | Day 15 | 
| 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 % | Day 15 | 
| Collisions | Number of collisions (on driving simulator) | Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Donepezil, Driving, Cholinesterase Inhibitors, Geriatric Psychiatry, Psychopharmacology, Aricept