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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health; Geriatrics
• Intervention / Treatment: Drug: donepezil; Drug: Placebo (cornstarch)

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 5E1
      • Lakehead University
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: donepezil; donepezil, capsule, 5mg daily once daily for 14 days	Drug: donepezil; Other Names: Aricept
Placebo Comparator: placebo; placebo (cornstarch), capsule, once daily for 14 days	Drug: Placebo (cornstarch)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Mark Rapoport, MD, FRCPC, University of Toronto; Study Chair: Michel Bedard, PhD, Lakehead University; Study Chair: Nathan Herrmann, MD, FRCPC, University of Toronto; Study Chair: Krista Lanctot, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: May 31, 2007
• First Submitted That Met QC Criteria: May 31, 2007
• First Posted (Estimate): June 4, 2007

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Driving; Cholinesterase Inhibitors; Donepezil; Psychopharmacology; Aricept; Geriatric Psychiatry
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: 458970