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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090116
• Other study ID #: NER-MD-02
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2004
• Last updated: March 1, 2012
• Start date: March 2003
• Est. completion date: March 2005

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Neramexane

Locations

Country	Name	City	State
United States	Upstate Clinical Research	Albany	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Mood and Memory Clinic of Michigan	Farmington Hills,	Michigan
United States	Baumel-Eisner Neuromedical Institute	Fort Lauderdale	Florida
United States	Margolin Brain Institute	Fresno	California
United States	Baumel-Eisner Neuromedical Institute	Ft. Lauderdale	Florida
United States	Berma Research Group	Hialeah	Florida
United States	Indiana Universisty Medical Center	Indianapolis	Indiana
United States	Alzheimer's Research Corporation	Lakehurst	New Jersey
United States	Lexington Clinic	Lexington	Kentucky
United States	Joel Ross, MD	Long Branch	New Jersey
United States	Pioneer Pharmaceutical Research	Midvale	Utah
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Pharmacology Research Institute	Northridge	California
United States	UCI Medical Center	Orange	California
United States	Nathan S. Kline Institute for Psychiatric Research	Orangeburg	New York
United States	Palm Beach Neurological Center	Palm Beach Gardens	Florida
United States	Pivotal Research Centers	Peoria	Arizona
United States	21st Century Neurology	Phoenix	Arizona
United States	Ubhc/Umdnj	Piscataway	New Jersey
United States	Neurology Clinical Research, Inc.	Plantation	Florida
United States	Summit Research Network	Portland	Oregon
United States	Monroe Community Hospital	Rochester	New York
United States	Affiliated Research Institute	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	J. Gary Booker, MD	Shreveport	Louisiana
United States	St. Louis University	St. Louis	Missouri
United States	Behavioral Medical Research of Saten Island, PC	Staten Island	New York
United States	University of South Florida	Tampa	Florida
United States	Neurology and Neuroscience Center of Ohio	Toledo	Ohio
United States	Palm Beach Neurology	West Palm Beach	Florida
United States	North Texas Neurology Research	Wichita	Texas
United States	Piedmont Medical Research	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States,