Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).
|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: 12 months ] [ Designated as safety issue: No ]
- The secondary outcome measures are the change from Baseline to End Point on driving-related measures; DriveABLE-On Road Test, ADAS-cog, FULD, Rey-Osterrieth Complex Figure Test, Trail Making Test, Useful Field of View, Motor Free Visual Perception Test. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Placebo BID for 12 months
|Active Comparator: Memantine||
Memantine (Namenda)10mg 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 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 Alzheimer's Disease (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.
|United States, Florida|
|Clinical Research Studies at Florida Atlantic University|
|Boca Raton, Florida, United States, 33431|
|Principal Investigator:||Peter J Holland, MD||College of Medicine at Florida Atlantic University|