The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease

NCT ID: NCT00090116

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-03-31

Brief Summary

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Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Neramexane

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of moderate to severe Alzheimer's disease;
* ambulatory patients

Exclusion Criteria

* folate deficiency;
* clinically significant central nervous system disease other than Alzheimer's disease;
* clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Pivotal Research Centers

Peoria, Arizona, United States

Site Status

21st Century Neurology

Phoenix, Arizona, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

Pharmacology Research Institute

Northridge, California, United States

Site Status

UCI Medical Center

Orange, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, United States

Site Status

Berma Research Group

Hialeah, Florida, United States

Site Status

Palm Beach Neurological Center

Palm Beach Gardens, Florida, United States

Site Status

Neurology Clinical Research, Inc.

Plantation, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Palm Beach Neurology

West Palm Beach, Florida, United States

Site Status

Indiana Universisty Medical Center

Indianapolis, Indiana, United States

Site Status

Lexington Clinic

Lexington, Kentucky, United States

Site Status

J. Gary Booker, MD

Shreveport, Louisiana, United States

Site Status

Mood and Memory Clinic of Michigan

Farmington Hills, Michigan, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

Alzheimer's Research Corporation

Lakehurst, New Jersey, United States

Site Status

Joel Ross, MD

Long Branch, New Jersey, United States

Site Status

Ubhc/Umdnj

Piscataway, New Jersey, United States

Site Status

Upstate Clinical Research

Albany, New York, United States

Site Status

Nathan S. Kline Institute for Psychiatric Research

Orangeburg, New York, United States

Site Status

Monroe Community Hospital

Rochester, New York, United States

Site Status

Behavioral Medical Research of Saten Island, PC

Staten Island, New York, United States

Site Status

Piedmont Medical Research

Winston-Salem, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

North Texas Neurology Research

Wichita, Texas, United States

Site Status

Pioneer Pharmaceutical Research

Midvale, Utah, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NER-MD-02

Identifier Type: -

Identifier Source: org_study_id

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