Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease|
- The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.
- Fuld Object Memory Evaluation [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity.
Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment.
- Rey Complex Figure Test [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment
- Trail Making Test - Part A [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.
- Trail Making Test - Part B [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.
- Mini Mental Status Exam [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]Scores range from 0-30 with lower scores indicating decreased functioning.
- Useful Field of View [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.
- Motor Free Visual Perception Test - Visual Closure Subtest [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.
- Cognitive Dementia Rating Scale [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.
|Study Start Date:||July 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
One tablet placebo morning and evening (BID) for 12 months
One tablet placebo morning and evening (BID) for 12 months
Active Comparator: Memantine
One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months.
One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
Other Name: Namenda
It is well known, and of great concern to both patients and families, that individuals with Alzheimer's disease (AD) eventually become driving impaired. Drivers with dementia are estimated to be 2-8 times more likely to be involved in an automobile crash as unimpaired peers. Approximately half of individuals with mild AD have the skills needed to drive safely. Formal driver evaluation may be necessary to make this distinction. Some reviews in the literature have suggested that individuals identified as high risk, such as those with AD, be advised by their physicians to cease driving altogether. Other studies suggest that these individuals may continue to drive for up to 4 years following diagnosis. Memantine may be effective in delaying the progression of driving impairment in individuals with mild AD. If the investigators can demonstrate a significant delay in the decline in the driving ability, this could extend their driving time and therefore be of immense benefit to patients and their caregivers.
Comparison(s): Subjects treated with memantine over a period of 12 months, compared to subjects on placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476008
|United States, Florida|
|Charles E. Schmidt College of Medicine, Florida Atlantic University|
|Boca Raton, Florida, United States, 33431|
|Principal Investigator:||Peter J Holland, MD||Charles E, Schmidt College of Medicine at Florida Atlantic University|