Mental HealthPhase 4NCT00482001
Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
A Phase 4 study testing donepezil in people with Mental Health and Geriatrics, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Geriatrics
- What is being tested?
- donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2007to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- psychiatric history
- sleep disorder history
- substance abuse
- neurological history
- medical illness
Show all 10Show fewer
- ophthalmological disease
- psychoactive medications
- contra-indications to Donepezil
- experience car/motion sickness
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Lakehead University
Thunder Bay, Ontario, P7B 5E1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study
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.
Read the 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.
- Conditions
- Mental Health, Geriatrics
- Being tested
- donepezil, Placebo (cornstarch)
- Keywords
- Donepezil, Driving, Cholinesterase Inhibitors, Geriatric Psychiatry, Psychopharmacology, Aricept
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezilDrug
Also called Aricept
Placebo (cornstarch)Drug
| Study group | Role | What they receive |
|---|---|---|
| donepezil | Experimental | donepezil, capsule, 5mg daily once daily for 14 days Receives: Drug: donepezil |
| placebo | Placebo comparator | placebo (cornstarch), capsule, once daily for 14 days Receives: Drug: Placebo (cornstarch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test (PVT)
A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Measured: Day 15
Attention Network Test (ANT)
A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus
Measured: Day 15
Speed Deviation
A measure of deviation from posted speed limit, measured in km/h
Measured: Day 15
Deviation From Road Position
A measure of deviation from central road position, measured in cm
Measured: Day 15
Reaction Time to Wind Gusts
Reaction time to wind gusts, measured in seconds
Measured: Day 15
Percentage of Time in Safe Zone
Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %
Measured: Day 15
Collisions
Number of collisions (on driving simulator)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Mark Rapoport, MD, FRCPC, Principal investigator, University of TorontoMichel Bedard, PhD, Study chair, Lakehead UniversityNathan Herrmann, MD, FRCPC, Study chair, University of TorontoKrista Lanctot, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482001
- Sponsor's protocol ID
- 458970
- Status last verified
- Feb 2019
- First submitted
- 31 May 2007
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT00482001
- Acronym / sponsor ID
- 458970
- Conditions
- Mental Health, Geriatrics
- Keywords
- Donepezil, Driving, Cholinesterase Inhibitors, Geriatric Psychiatry, Psychopharmacology, Aricept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| donepezil | Experimental | Drug: donepezildonepezil, capsule, 5mg daily once daily for 14 days |
| placebo | Placebo comparator | Drug: Placebo (cornstarch)placebo (cornstarch), capsule, once daily for 14 days |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- cognitive impairment
- psychiatric history
- sleep disorder history
- substance abuse
- neurological history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donepezilAlso: Aricept | Drug | donepezil |
| Placebo (cornstarch) | Drug | placebo |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rapoport, MD, FRCPC principal investigator
University of Toronto
Michel Bedard, PhD study chair
Lakehead University
Nathan Herrmann, MD, FRCPC study chair
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing donepezil in people with Mental Health and Geriatrics, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Vigilance Test (PVT) (time frame: Day 15). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.