Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482001
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2007-05-31
Brief Title:
Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
Alzheimers 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 5mgday 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
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 5mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None