Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Health Geriatrics |
Drug: donepezil Drug: Placebo (cornstarch) |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 22 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: donepezil
donepezil 5mg, once daily for 2 weeks
Other Name: Aricept
|
| Placebo Comparator: 2 |
Drug: Placebo (cornstarch)
1 capsule daily for 2 weeks
|
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.
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | 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
Contacts and Locations| Canada, Ontario | |
| Lakehead University | |
| 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 |
More Information
No publications provided
| Responsible Party: | Mark J Rapoport, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00482001 History of Changes |
| Other Study ID Numbers: | 458970 |
| Study First Received: | May 31, 2007 |
| Last Updated: | February 5, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Donepezil Driving Cholinesterase Inhibitors |
Geriatric Psychiatry Psychopharmacology Aricept |
Additional relevant MeSH terms:
|
Cholinesterase Inhibitors Donepezil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents |
Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013