The Impact of Cognitive Impairment on Driving Safety.
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-008232
Sponsor Protocol Number: 13-008232
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