NCT00857649

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

A Randomised, Double-Blind, Parallel-Group Study Examining the Efficacy and Safety of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.

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. This 24-week randomised, double-blind, placebo-controlled, multicentre study examines the effect of memantine 20 mg, administered once daily, on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD and significant psychopathology.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Memantine	20 mg Oral Tablets Once Daily
DRUG	Placebo	Oral Tablets Once Daily

Timeline

• Start date: 2003-12-01
• Primary completion: 2010-04-01
• Completion: 2010-09-01
• First posted: 2009-03-06
• Last updated: 2013-12-05
• Results posted: 2012-01-09

Locations

23 sites across 1 country: Canada