Phase 4 N=22 Randomized Quadruple-blind Supportive Care

Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Mental Health · Geriatrics

Bottom Line

View on ClinicalTrials.gov: NCT00482001 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Psychomotor Vigilance Test (PVT) — 302.62; 277.13 milliseconds

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: donepezil (Drug); Placebo (cornstarch) (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Sunnybrook Health Sciences Centre
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Psychomotor Vigilance Test (PVT)	302.62; 277.13	—
PRIMARY Attention Network Test (ANT)	672.37; 637.58	—
PRIMARY Speed Deviation	-1.09; -2.41	—
PRIMARY Deviation From Road Position	27.54; 26.06	—
PRIMARY Reaction Time to Wind Gusts	1.69; 1.18	—
PRIMARY Percentage of Time in Safe Zone	60.95; 74.79	—
PRIMARY Collisions	0.40; 0.30	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00482001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.