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临床试验/NCT00482001
NCT00482001已完成4 期

The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
22
试验地点
2
主要终点
Psychomotor Vigilance Test (PVT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • valid Ontario driver's license
  • active driver (greater than or equal to three times per week)
  • written, informed consent
  • lives in Toronto/Thunder Bay
  • Male between 65-75 years old

排除标准

  • 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

研究组 & 干预措施

donepezil

Experimental

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

干预措施: donepezil (Drug)

placebo

Placebo Comparator

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

干预措施: Placebo (cornstarch) (Drug)

结局指标

主要结局

Psychomotor Vigilance Test (PVT)

时间窗: Day 15

A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus

Speed Deviation

时间窗: Day 15

A measure of deviation from posted speed limit, measured in km/h

Attention Network Test (ANT)

时间窗: Day 15

A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus

Deviation From Road Position

时间窗: Day 15

A measure of deviation from central road position, measured in cm

Reaction Time to Wind Gusts

时间窗: Day 15

Reaction time to wind gusts, measured in seconds

Percentage of Time in Safe Zone

时间窗: Day 15

Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %

Collisions

时间窗: Day 15

Number of collisions (on driving simulator)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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