Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
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.
Drug: Placebo (cornstarch)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study|
- General performance and errors made on a computer-simulated driving test [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
donepezil 5mg, once daily for 2 weeks
Other Name: Aricept
|Placebo Comparator: 2||
Drug: Placebo (cornstarch)
1 capsule daily for 2 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482001
|Thunder Bay, Ontario, Canada, P7B 5E1|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|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|