Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| donepezil | Experimental | donepezil, capsule, 5mg daily once daily for 14 days |
|
| placebo | Placebo Comparator | placebo (cornstarch), capsule, once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donepezil | Drug |
|
| |
| Placebo (cornstarch) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor Vigilance Test (PVT) | A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus | 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 | Day 15 |
| Speed Deviation | A measure of deviation from posted speed limit, measured in km/h | Day 15 |
| Deviation From Road Position | A measure of deviation from central road position, measured in cm | Day 15 |
| Reaction Time to Wind Gusts | Reaction time to wind gusts, measured in seconds | 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 % | Day 15 |
| Collisions | Number of collisions (on driving simulator) | Day 15 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Rapoport, MD, FRCPC | University of Toronto | Principal Investigator |
| Michel Bedard, PhD | Lakehead University | Study Chair |
| Nathan Herrmann, MD, FRCPC | University of Toronto | Study Chair |
| Krista Lanctot, PhD | University of Toronto | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakehead University | Thunder Bay | Ontario | P7B 5E1 | Canada | ||
| Sunnybrook Health Sciences Centre |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | donepezil: donepezil 5mg, once daily for 2 weeks |
| FG001 | Placebo | Placebo (cornstarch): 1 capsule daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | donepezil: donepezil 5mg, once daily for 2 weeks |
| BG001 | Placebo | Placebo (cornstarch): 1 capsule daily for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psychomotor Vigilance Test (PVT) | A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus | Posted | Mean | Standard Deviation | milliseconds | Day 15 |
|
|
Day 8
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil | donepezil 5mg, one capsule daily for 14 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anorexia | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Rapoport | Sunnybrook Health Sciences Centre | 416-480-4085 | Mark.Rapoport@sunnybrook.ca |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077265 | Donepezil |
| D013213 | Starch |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| number of driving days/week | Mean | Standard Deviation | days |
|
| Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE), range 0-30, with higher scores indicating better mental state/ cognitive performance | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | milliseconds | Day 15 |
|
|
|
| Primary | Speed Deviation | A measure of deviation from posted speed limit, measured in km/h | Posted | Mean | Standard Deviation | kilometers / hour | Day 15 |
|
|
|
| Primary | Deviation From Road Position | A measure of deviation from central road position, measured in cm | Posted | Mean | Standard Deviation | centimeters | Day 15 |
|
|
|
| Primary | Reaction Time to Wind Gusts | Reaction time to wind gusts, measured in seconds | Posted | Mean | Standard Deviation | seconds | Day 15 |
|
|
|
| Primary | 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 % | Posted | Mean | Standard Deviation | percentage of time | Day 15 |
|
|
|
| Primary | Collisions | Number of collisions (on driving simulator) | Posted | Mean | Standard Deviation | collisions | Day 15 |
|
|
|
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | Placebo | Placebo (cornstarch), 1 capsule daily for 14 days | 0 | 11 | 7 | 11 |
| nausea / diarrhea | General disorders | Systematic Assessment |
|
| fatigue / somnolence | General disorders | Systematic Assessment |
|
| headaches / abnormal dreams | General disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| frequent urination | General disorders | Systematic Assessment |
|
| thirst | General disorders | Systematic Assessment |
|
| rash | General disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |