Clinical Trials Directory

Trials / Completed

CompletedNCT00482001

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
65 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGdonepezil
DRUGPlacebo (cornstarch)

Timeline

Start date
2007-06-01
Primary completion
2008-08-01
Completion
2008-08-01
First posted
2007-06-04
Last updated
2019-05-10
Results posted
2019-05-10

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00482001. Inclusion in this directory is not an endorsement.