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A Study of the Safety and Eff...

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

Last Updated: 2010-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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

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Dementia of the Alzheimer's Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Oral administration, once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo oral administration once daily.

Memantine ER

28mg, once daily. Oral administration for 24 weeks.

Group Type ACTIVE_COMPARATOR

memantine ER

Intervention Type DRUG

28mg(7mg capsules) once daily and oral administration for 24 weeks.

Interventions

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memantine ER

28mg(7mg capsules) once daily and oral administration for 24 weeks.

Intervention Type DRUG

Placebo

Matching placebo oral administration once daily.

Intervention Type DRUG

Other Intervention Names

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Namenda XR

Eligibility Criteria

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Inclusion Criteria

* Ambulatory patients aged \>/= 50 years
* Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
* Mini-Mental State Examination (MMSE) scores \>/= 3 and \</= 14 at Screening (Visit 1) and Baseline (Visit 2)
* Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria

* Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
* Patients who have taken memantine within one month of Screening (Visit 1)
* Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
* Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
* Patients who are receiving therapy with more than one AChEI.
* Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
* Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
* Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
* Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
* Patients who had dementia that was complicated by other organic disease
* Patients who had dementia complicated by the presence of predominant delusions

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Forest Research Institute, a subsidiary of Forest Laboratories, Inc

Principal Investigators

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Stephen M Graham, PhD

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 010

Phoenix, Arizona, United States

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Forest Investigative Site 062

Costa Mesa, California, United States

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Forest Investigative Site 050

Fresno, California, United States

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Forest Investigative Site 024

San Francisco, California, United States

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Forest Investigative Site 071

Santa Ana, California, United States

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Forest Investigative Site 002

Denver, Colorado, United States

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Forest Investigative Site 021

Boca Raton, Florida, United States

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Forest Investigative Site 052

Boynton Beach, Florida, United States

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Forest Investigative Site 070

Delray Beach, Florida, United States

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Forest Investigative Site 065

Fort Myers, Florida, United States

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Forest Investigative Site 043

Hallandale, Florida, United States

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Forest Investigative Site 044

Hallandale, Florida, United States

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Forest Investigative Site 001

Miami, Florida, United States

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Forest Investigative Site 034

North Miami, Florida, United States

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Forest Investigative Site 068

Orlando, Florida, United States

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Forest Investigative Site 038

Palm Beach Gardens, Florida, United States

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Forest Investigative Site 008

St. Petersburg, Florida, United States

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Forest Investigative Site 028

Tampa, Florida, United States

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Forest Investigative Site 009

Snellville, Georgia, United States

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Forest Investigative Site 069

Joliet, Illinois, United States

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Forest Investigative Site 045

Kalamazoo, Michigan, United States

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Forest Investigative Site 014

Saint Loius, Missouri, United States

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Forest Investigative Site 064

Long Branch, New Jersey, United States

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Forest Investigative Site 011

Morristown, New Jersey, United States

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Forest Investigative Site 003

New Brunswick, New Jersey, United States

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Forest Investigative Site 048

Albany, New York, United States

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Forest Investigative Site 006

Buffalo, New York, United States

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Forest Investigative Site 004

White Plains, New York, United States

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Forest Investigative Site 027

Centerville, Ohio, United States

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Forest Investigative Site 012

Toledo, Ohio, United States

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Forest Investigative Site 020

Portland, Oregon, United States

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Forest Investigative Site 032

Greensburg, Pennsylvania, United States

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Forest Investigative Site 018

Jenkintown, Pennsylvania, United States

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Forest Investigative Site 067

East Providence, Rhode Island, United States

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Forest Investigative Site 041

Austin, Texas, United States

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Forest Investigative Site 017

San Antonio, Texas, United States

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Forest Investigative Site 013

Richmond, Virginia, United States

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Forest Investigative Site 026

Tacoma, Washington, United States

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