NCT00322153

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

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Detailed description

Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Conditions

• Dementia of the Alzheimer's Type

Interventions

Type	Name	Description
DRUG	memantine ER	28mg(7mg capsules) once daily and oral administration for 24 weeks.
DRUG	Placebo	Matching placebo oral administration once daily.

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-10-01
• Completion: 2008-01-01
• First posted: 2006-05-05
• Last updated: 2010-09-16
• Results posted: 2010-09-16

Locations

83 sites across 4 countries: United States, Argentina, Chile, Mexico