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

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

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Neramexane

• Study Type: Interventional
• Enrollment: 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Centers
    • Phoenix, Arizona, United States, 85013
      • 21st Century Neurology
  • California
    • Fresno, California, United States, 93720
      • Margolin Brain Institute
    • Northridge, California, United States, 91324
      • Pharmacology Research Institute
    • Orange, California, United States, 92868
      • UCI Medical Center
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92108
      • Affiliated Research Institute
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado Health Sciences Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Florida
    • Fort Lauderdale, Florida, United States, 33321
      • Baumel-Eisner Neuromedical Institute
    • Ft. Lauderdale, Florida, United States, 33321
      • Baumel-Eisner Neuromedical Institute
    • Hialeah, Florida, United States, 33016
      • Berma Research Group
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Neurological Center
    • Plantation, Florida, United States, 33324
      • Neurology Clinical Research, Inc.
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Universisty Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Lexington Clinic
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • J. Gary Booker, Md
  • Michigan
    • Farmington Hills,, Michigan, United States, 48334
      • Mood and Memory Clinic of Michigan
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • St. Louis University
  • New Jersey
    • Lakehurst, New Jersey, United States, 08733
      • Alzheimer's Research Corporation
    • Long Branch, New Jersey, United States, 07740
      • Joel Ross, MD
    • Piscataway, New Jersey, United States, 08855
      • Ubhc/Umdnj
  • New York
    • Albany, New York, United States, 12205
      • Upstate Clinical Research
    • Orangeburg, New York, United States, 10962
      • Nathan S. Kline Institute for Psychiatric Research
    • Rochester, New York, United States, 14620
      • Monroe Community Hospital
    • Staten Island, New York, United States, 10305
      • Behavioral Medical Research of Saten Island, PC
  • North Carolina
    • Winston Salem, North Carolina, United States, 27103
      • Piedmont Medical Research
  • Ohio
    • Columbus, Ohio, United States, 443210
      • Ohio State University
    • Toledo, Ohio, United States, 43623
      • Neurology and Neuroscience Center of Ohio
  • Oregon
    • Portland, Oregon, United States, 97223
      • Summit Research Network
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina
  • Texas
    • Wichita, Texas, United States, 76301
      • North Texas Neurology Research
  • Utah
    • Midvale, Utah, United States, 84047
      • Pioneer Pharmaceutical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Collaborators and Investigators

• Sponsor: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (ACTUAL): March 1, 2005
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: August 24, 2004
• First Submitted That Met QC Criteria: August 25, 2004
• First Posted (ESTIMATE): August 26, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Memory Loss; NMDA receptor antagonist; Neramexane
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: NER-MD-02