Trial Outcomes & Findings for Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults (NCT NCT00482001)
NCT ID: NCT00482001
Last Updated: 2019-05-10
Results Overview
A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Day 15
Results posted on
2019-05-10
Participant Flow
Participant milestones
| Measure |
Donepezil
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Donepezil
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 5.6 • n=10 Participants
|
70.8 years
STANDARD_DEVIATION 4.7 • n=10 Participants
|
71.7 years
STANDARD_DEVIATION 5.1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
number of driving days/week
|
6.55 days
STANDARD_DEVIATION 1.0 • n=10 Participants
|
5.80 days
STANDARD_DEVIATION 1.6 • n=10 Participants
|
6.18 days
STANDARD_DEVIATION 1.35 • n=20 Participants
|
|
Mini-Mental State Examination (MMSE)
|
29.30 units on a scale
STANDARD_DEVIATION 1.1 • n=10 Participants
|
29.50 units on a scale
STANDARD_DEVIATION 0.7 • n=10 Participants
|
29.4 units on a scale
STANDARD_DEVIATION 0.9 • n=20 Participants
|
PRIMARY outcome
Timeframe: Day 15A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Psychomotor Vigilance Test (PVT)
|
302.62 milliseconds
Standard Deviation 53.0
|
277.13 milliseconds
Standard Deviation 23.9
|
PRIMARY outcome
Timeframe: Day 15A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Attention Network Test (ANT)
|
672.37 milliseconds
Standard Deviation 70.9
|
637.58 milliseconds
Standard Deviation 68.7
|
PRIMARY outcome
Timeframe: Day 15A measure of deviation from posted speed limit, measured in km/h
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Speed Deviation
|
-1.09 kilometers / hour
Standard Deviation 6.6
|
-2.41 kilometers / hour
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Day 15A measure of deviation from central road position, measured in cm
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Deviation From Road Position
|
27.54 centimeters
Standard Deviation 1.1
|
26.06 centimeters
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Day 15Reaction time to wind gusts, measured in seconds
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Reaction Time to Wind Gusts
|
1.69 seconds
Standard Deviation 0.5
|
1.18 seconds
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Day 15Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Percentage of Time in Safe Zone
|
60.95 percentage of time
Standard Deviation 21.4
|
74.79 percentage of time
Standard Deviation 17.6
|
PRIMARY outcome
Timeframe: Day 15Number of collisions (on driving simulator)
Outcome measures
| Measure |
Donepezil
n=10 Participants
donepezil: donepezil 5mg, once daily for 2 weeks
|
Placebo
n=10 Participants
Placebo (cornstarch): 1 capsule daily for 2 weeks
|
|---|---|---|
|
Collisions
|
0.40 collisions
Standard Deviation 0.7
|
0.30 collisions
Standard Deviation 0.5
|
Adverse Events
Donepezil
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Donepezil
n=11 participants at risk
donepezil 5mg, one capsule daily for 14 days
|
Placebo
n=11 participants at risk
Placebo (cornstarch), 1 capsule daily for 14 days
|
|---|---|---|
|
General disorders
anorexia
|
0.00%
0/11 • Day 8
|
9.1%
1/11 • Number of events 1 • Day 8
|
|
General disorders
nausea / diarrhea
|
9.1%
1/11 • Number of events 1 • Day 8
|
0.00%
0/11 • Day 8
|
|
General disorders
fatigue / somnolence
|
18.2%
2/11 • Number of events 2 • Day 8
|
18.2%
2/11 • Number of events 2 • Day 8
|
|
General disorders
headaches / abnormal dreams
|
18.2%
2/11 • Number of events 2 • Day 8
|
9.1%
1/11 • Number of events 1 • Day 8
|
|
General disorders
insomnia
|
9.1%
1/11 • Number of events 1 • Day 8
|
0.00%
0/11 • Day 8
|
|
General disorders
frequent urination
|
45.5%
5/11 • Number of events 5 • Day 8
|
0.00%
0/11 • Day 8
|
|
General disorders
thirst
|
0.00%
0/11 • Day 8
|
9.1%
1/11 • Number of events 1 • Day 8
|
|
General disorders
rash
|
0.00%
0/11 • Day 8
|
9.1%
1/11 • Number of events 1 • Day 8
|
|
General disorders
dry mouth
|
0.00%
0/11 • Day 8
|
9.1%
1/11 • Number of events 1 • Day 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place