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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Neramexane
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pivotal Research Centers
  • 21st Century Neurology
  • Margolin Brain Institute
  • Pharmacology Research Institute
  • UCI Medical Center
  • Pacific Research Network
  • Affiliated Research Institute
  • University of Colorado Health Sciences Center
  • Yale University School of Medicine
  • Baumel-Eisner Neuromedical Institute
  • Baumel-Eisner Neuromedical Institute
  • Berma Research Group
  • Palm Beach Neurological Center
  • Neurology Clinical Research, Inc.
  • University of South Florida
  • Palm Beach Neurology
  • Indiana Universisty Medical Center
  • Lexington Clinic
  • J. Gary Booker, MD
  • Mood and Memory Clinic of Michigan
  • St. Louis University
  • Alzheimer's Research Corporation
  • Joel Ross, MD
  • Ubhc/Umdnj
  • Upstate Clinical Research
  • Nathan S. Kline Institute for Psychiatric Research
  • Monroe Community Hospital
  • Behavioral Medical Research of Saten Island, PC
  • Piedmont Medical Research
  • Ohio State University
  • Neurology and Neuroscience Center of Ohio
  • Summit Research Network
  • Medical University of South Carolina
  • North Texas Neurology Research
  • Pioneer Pharmaceutical Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 24, 2004
Last Updated
March 1, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00090116
Brief Title
The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Neramexane

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Indiana Universisty Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
J. Gary Booker, MD
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Mood and Memory Clinic of Michigan
City
Farmington Hills,
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Alzheimer's Research Corporation
City
Lakehurst
State/Province
New Jersey
ZIP/Postal Code
08733
Country
United States
Facility Name
Joel Ross, MD
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Ubhc/Umdnj
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08855
Country
United States
Facility Name
Upstate Clinical Research
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Behavioral Medical Research of Saten Island, PC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Piedmont Medical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
443210
Country
United States
Facility Name
Neurology and Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
North Texas Neurology Research
City
Wichita
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Pioneer Pharmaceutical Research
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.alzheimers.org
Description
Related Info

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

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