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| Sponsor: | Sunnybrook Health Sciences Centre |
|---|---|
| Collaborator: |
University of Toronto |
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00482001 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study |
| 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 |
|---|---|
| 1: Experimental |
Drug: donepezil
donepezil 5mg, once daily for 2 weeks
|
| 2: Placebo Comparator |
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.
Eligibility| Ages Eligible for Study: | 65 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Lakehead University | |
| Thunder Bay, Ontario, Canada, P7B 5E1 | |
| 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
| Responsible Party: | Sunnybrook Health Sciences Centre ( Mark J Rapoport ) |
| Study ID Numbers: | 458970 |
| Study First Received: | May 31, 2007 |
| Last Updated: | February 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00482001 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Donepezil Driving Cholinesterase Inhibitors |
Geriatric Psychiatry Psychopharmacology Aricept |
|
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Donepezil Enzyme Inhibitors Cholinergic Agents Central Nervous System Agents Pharmacologic Actions |
