Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 4

Conditions: Geriatrics; Mental Health

Treatments: Drug: Placebo (cornstarch); Drug: donepezil

Study type: Interventional

Funder types: Other

Identifiers

NCT00482001

458970

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

donepezil

Experimental group

Description:

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

Treatment:

Drug: donepezil

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (cornstarch)