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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

Tracking Information
First Submitted Date  ICMJE May 31, 2007
First Posted Date  ICMJE June 4, 2007
Results First Submitted Date  ICMJE June 22, 2017
Results First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Study Start Date  ICMJE June 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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
  • 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
  • Speed Deviation [ Time Frame: Day 15 ]
    A measure of deviation from posted speed limit, measured in km/h
  • Deviation From Road Position [ Time Frame: Day 15 ]
    A measure of deviation from central road position, measured in cm
  • Reaction Time to Wind Gusts [ Time Frame: Day 15 ]
    Reaction time to wind gusts, measured in seconds
  • 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 %
  • Collisions [ Time Frame: Day 15 ]
    Number of collisions (on driving simulator)
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2007)
General performance and errors made on a computer-simulated driving test [ Time Frame: 30 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
Official Title  ICMJE The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Mental Health
  • Geriatrics
Intervention  ICMJE
  • Drug: donepezil
    Other Name: Aricept
  • Drug: Placebo (cornstarch)
Study Arms  ICMJE
  • Experimental: donepezil
    donepezil, capsule, 5mg daily once daily for 14 days
    Intervention: Drug: donepezil
  • Placebo Comparator: placebo
    placebo (cornstarch), capsule, once daily for 14 days
    Intervention: Drug: Placebo (cornstarch)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2007)
20
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482001
Other Study ID Numbers  ICMJE 458970
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE University of Toronto
Investigators  ICMJE
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
PRS Account Sunnybrook Health Sciences Centre
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP