NCT00857233

Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease

An Open-label Extension Study Examining the Safety and Tolerability of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type Having Completed Study 10158

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.

Detailed description

Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline. The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158. In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Memantine	20 mg oral tablets once daily

Timeline

• Start date: 2004-06-01
• Primary completion: 2010-07-01
• Completion: 2010-10-01
• First posted: 2009-03-06
• Last updated: 2012-08-29
• Results posted: 2012-08-29

Locations

33 sites across 1 country: Canada