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Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482001
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Mental Health Geriatrics Drug: donepezil Drug: Placebo (cornstarch) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: donepezil
donepezil, capsule, 5mg daily once daily for 14 days
Drug: donepezil
Other Name: Aricept

Placebo Comparator: placebo
placebo (cornstarch), capsule, once daily for 14 days
Drug: Placebo (cornstarch)



Primary Outcome Measures :
  1. Psychomotor Vigilance Test (PVT) [ Time Frame: Day 15 ]
    A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus

  2. Attention Network Test (ANT) [ Time Frame: Day 15 ]
    A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus

  3. Speed Deviation [ Time Frame: Day 15 ]
    A measure of deviation from posted speed limit, measured in km/h

  4. Deviation From Road Position [ Time Frame: Day 15 ]
    A measure of deviation from central road position, measured in cm

  5. Reaction Time to Wind Gusts [ Time Frame: Day 15 ]
    Reaction time to wind gusts, measured in seconds

  6. Percentage of Time in Safe Zone [ Time Frame: Day 15 ]
    Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %

  7. Collisions [ Time Frame: Day 15 ]
    Number of collisions (on driving simulator)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482001


Locations
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Canada, Ontario
Lakehead University
Thunder Bay, Ontario, Canada, P7B 5E1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
Investigators
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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
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00482001    
Other Study ID Numbers: 458970
First Posted: June 4, 2007    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019
Last Verified: February 2019
Keywords provided by Sunnybrook Health Sciences Centre:
Donepezil
Driving
Cholinesterase Inhibitors
Geriatric Psychiatry
Psychopharmacology
Aricept
Additional relevant MeSH terms:
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Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents