Official Title: “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 Type: Interventional

Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: donepezil
  • donepezil 5mg, once daily for 2 weeks
• Drug: Placebo (cornstarch)
  • 1 capsule daily for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• General performance and errors made on a computer-simulated driving test
  • Time Frame: 30 minutes
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Sunnybrook Health Sciences Centre

Overall Clinical Trial Officials and Contacts

Mark Rapoport, MD, FRCPC Principal Investigator University of Toronto  

Overall Contact: Mark Rapoport, MD, FRCPC 416-480-4085 mark.rapoport@sunnybrook.ca

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00482001

Study ID Number: 458970

ClinicalTrials.gov Identifier: NCT00482001

Health Authority: Canada: Ethics Review Committee