Viewing Study NCT00476008



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00476008
Status: COMPLETED
Last Update Posted: 2014-08-11
First Post: 2007-05-17

Brief Title: Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimers Disease
Sponsor: Florida Atlantic University
Organization: Florida Atlantic University

Study Overview

Official Title: Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimers Disease
Status: COMPLETED
Status Verified Date: 2014-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimers Disease AD
Detailed Description: It is well known and of great concern to both patients and families that individuals with Alzheimers 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

Comparisons Subjects treated with memantine over a period of 12 months compared to subjects on placebo

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None