Clinical trial NCT00482001: Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
Official title: The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mental Health
Geriatrics
Keywords: Donepezil
Driving
Cholinesterase Inhibitors
Geriatric Psychiatry
Psychopharmacology
Aricept
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2007-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Psychomotor Vigilance Test (PVT)
timeFrame: Day 15
measure: Attention Network Test (ANT)
timeFrame: Day 15
measure: Speed Deviation
timeFrame: Day 15
measure: Deviation From Road Position
timeFrame: Day 15
measure: Reaction Time to Wind Gusts
timeFrame: Day 15
measure: Percentage of Time in Safe Zone
timeFrame: Day 15
measure: Collisions
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Mark Rapoport, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Lakehead University
name: Michel Bedard, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: Nathan Herrmann, MD, FRCPC
role: STUDY_CHAIR
affiliation: University of Toronto
name: Krista Lanctot, PhD
role: STUDY_CHAIR
References: