The Impact of Cognitive Impairment on Driving Safety.

Overview

About this study

Automobile driving is a crucial aspect of everyday life, but driving safety problems including car crashes or speeding violations are a serious public health problem. Alzheimer’s Disease (AD) affects the ability to safely drive and raises crash risk. Mild cognitive impairment (MCI) raises the risk of dementia, and people with MCI have been shown to have problems with memory, decision making, and the ability to concentrate that could lead to unsafe driving, even before obvious dementia begins. Whether MCI patients who continue to drive are safe drivers or not is unknown.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

MCI and early AD subjects

  • Licensed drivers aged 50-80 years,
  • Primary/principle drivers in their households, and living independently by themselves, or along with a spouse or significant other.
  • Subjects will be diagnosed with MCI or early AD according to standard clinical diagnostic criteria

Controls

  • Licensed drivers aged 50-80 without known neurological, psychiatric, or sleep disorders,
  • No history of cognitive or memory complaint symptoms,
  • Required to manifest a normal bedside mental status score (i.e., 35 or higher total score with 3 of 4 items retained on the memory subtask on the Kokmen Short Test of Mental Status (STMS), or 28 or higher on the Folstein Mini-Mental State Examination, MMSE)

Exclusion Criteria:

  • Patient and control subjects without an active driver license
  • Individuals with known neurological disorders (or in case of MCI/early AD subjects, a known associated etiology such as a brain lesion, known diagnosis of parkinsonism, mild cognitive impairment, or dementia),
  • Significant co-morbid medical or psychiatric disorder that could impact cognition (i.e., hepatic or renal insufficiency, active cancer diagnosis, active depression or anxiety disorder),
  •  Individuals receiving centrally active prescription medications (i.e., antidepressants other than low to moderate dose SSRIs, opiate analgesics, or antipsychotics) will be excluded.
  • Controls with STMS scores under 35 or MMSE scores under 28
  • Individuals with a history of severe motion sickness,
  • Corrected visual acuity of less than 20/50
  • Labile hypertension or tachycardia (blood pressure > 180 mm Hg systolic, or 110 mm Hg diastolic, or pulse over 120 beats per minute)
  • Untreated moderately severe or severe obstructive or central sleep apnea .
  • Potential participants for whom English is not their first language will be excluded since the driving and neuropsychological tests are presented in English.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Erik St Louis, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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CLS-20151564

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