Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482001
• Other study ID #: 458970
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Geriatrics
• Mental Health

Intervention

Drug:
• donepezil

• Placebo (cornstarch)

Locations

Country	Name	City	State
Canada	Lakehead University	Thunder Bay	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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	Day 15
Primary	Speed Deviation	A measure of deviation from posted speed limit, measured in km/h	Day 15
Primary	Deviation From Road Position	A measure of deviation from central road position, measured in cm	Day 15
Primary	Reaction Time to Wind Gusts	Reaction time to wind gusts, measured in seconds	Day 15
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 %	Day 15
Primary	Collisions	Number of collisions (on driving simulator)	Day 15