NCT00476008

Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Florida Atlantic University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).

Detailed description

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Memantine	One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
DRUG	Placebo	One tablet placebo morning and evening (BID) for 12 months

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2007-05-21
• Last updated: 2014-08-11
• Results posted: 2014-06-03

Locations

1 site across 1 country: United States