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Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Mental Health
Geriatrics
Interventions Drug: donepezil
Drug: Placebo (cornstarch)
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description donepezil: donepezil 5mg, once daily for 2 weeks Placebo (cornstarch): 1 capsule daily for 2 weeks
Period Title: Overall Study
Started 11 11
Completed 10 10
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             1
Arm/Group Title Donepezil Placebo Total
Hide Arm/Group Description donepezil: donepezil 5mg, once daily for 2 weeks Placebo (cornstarch): 1 capsule daily for 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
72.5  (5.6) 70.8  (4.7) 71.7  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
5
  50.0%
9
  45.0%
Male
6
  60.0%
5
  50.0%
11
  55.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
number of driving days/week  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 10 participants 20 participants
6.55  (1.0) 5.80  (1.6) 6.18  (1.35)
Mini-Mental State Examination (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 10 participants 20 participants
29.30  (1.1) 29.50  (0.7) 29.4  (0.9)
[1]
Measure Description: Mini-Mental State Examination (MMSE), range 0-30, with higher scores indicating better mental state/ cognitive performance
1.Primary Outcome
Title Psychomotor Vigilance Test (PVT)
Hide Description A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: milliseconds
302.62  (53.0) 277.13  (23.9)
2.Primary Outcome
Title Attention Network Test (ANT)
Hide Description A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil, capsule, 5mg daily once daily for 14 days

donepezil

placebo (cornstarch), capsule, once daily for 14 days

Placebo (cornstarch)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: milliseconds
672.37  (70.9) 637.58  (68.7)
3.Primary Outcome
Title Speed Deviation
Hide Description A measure of deviation from posted speed limit, measured in km/h
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: kilometers / hour
-1.09  (6.6) -2.41  (4.8)
4.Primary Outcome
Title Deviation From Road Position
Hide Description A measure of deviation from central road position, measured in cm
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: centimeters
27.54  (1.1) 26.06  (1.7)
5.Primary Outcome
Title Reaction Time to Wind Gusts
Hide Description Reaction time to wind gusts, measured in seconds
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: seconds
1.69  (0.5) 1.18  (0.3)
6.Primary Outcome
Title Percentage of Time in Safe Zone
Hide Description Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of time
60.95  (21.4) 74.79  (17.6)
7.Primary Outcome
Title Collisions
Hide Description Number of collisions (on driving simulator)
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
donepezil: donepezil 5mg, once daily for 2 weeks
Placebo (cornstarch): 1 capsule daily for 2 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: collisions
0.40  (0.7) 0.30  (0.5)
Time Frame Day 8
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description donepezil 5mg, one capsule daily for 14 days Placebo (cornstarch), 1 capsule daily for 14 days
All-Cause Mortality
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Donepezil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Donepezil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      7/11 (63.64%)    
General disorders     
anorexia   0/11 (0.00%)  0 1/11 (9.09%)  1
nausea / diarrhea   1/11 (9.09%)  1 0/11 (0.00%)  0
fatigue / somnolence   2/11 (18.18%)  2 2/11 (18.18%)  2
headaches / abnormal dreams   2/11 (18.18%)  2 1/11 (9.09%)  1
insomnia   1/11 (9.09%)  1 0/11 (0.00%)  0
frequent urination   5/11 (45.45%)  5 0/11 (0.00%)  0
thirst   0/11 (0.00%)  0 1/11 (9.09%)  1
rash   0/11 (0.00%)  0 1/11 (9.09%)  1
dry mouth   0/11 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Rapoport
Organization: Sunnybrook Health Sciences Centre
Phone: 416-480-4085
EMail: Mark.Rapoport@sunnybrook.ca
Layout table for additonal information
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00482001    
Other Study ID Numbers: 458970
First Submitted: May 31, 2007
First Posted: June 4, 2007
Results First Submitted: June 22, 2017
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019