Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

NCT ID: NCT00482001

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-08-31

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.

Detailed Description

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.

Conditions

Mental Health; Geriatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

donepezil

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

Group Type: EXPERIMENTAL

donepezil

Intervention Type: DRUG

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo (cornstarch)

Intervention Type: DRUG

Interventions

donepezil

Intervention Type: DRUG

Placebo (cornstarch)

Intervention Type: DRUG

Other Intervention Names

Aricept

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Rapoport, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Michel Bedard, PhD

Role: STUDY_CHAIR

Lakehead University

Nathan Herrmann, MD, FRCPC

Role: STUDY_CHAIR

University of Toronto

Krista Lanctot, PhD

Role: STUDY_CHAIR

University of Toronto

Locations

Lakehead University

Thunder Bay, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

458970

Identifier Type: -

Identifier Source: org_study_id