NCT00482001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

May 31, 2007

Results QC Date

June 22, 2017

Last Update Submit

February 13, 2019

Conditions

Mental HealthGeriatrics

Keywords

DonepezilDrivingCholinesterase InhibitorsGeriatric PsychiatryPsychopharmacologyAricept

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

donepezil

EXPERIMENTAL

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

Drug: donepezil

placebo

PLACEBO COMPARATOR

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

Drug: Placebo (cornstarch)

Interventions

donepezilDRUG
Also known as: Aricept
donepezil
Placebo (cornstarch)DRUG
placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

DonepezilStarch

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Results Point of Contact

Title
Dr. Mark Rapoport
Organization
Sunnybrook Health Sciences Centre
Mark.Rapoport@sunnybrook.ca
416-480-4085

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 4, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 10, 2019

Results First Posted

May 10, 2019

Record last verified: 2019-02

Locations

CA(2)