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
1 other identifier
interventional
400
1 country
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2003
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 24, 2004
CompletedFirst Posted
Study publicly available on registry
August 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedMarch 5, 2012
March 1, 2012
2 years
August 24, 2004
March 1, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of moderate to severe Alzheimer's disease;
- ambulatory patients
You may not qualify if:
- folate deficiency;
- clinically significant central nervous system disease other than Alzheimer's disease;
- clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
21st Century Neurology
Phoenix, Arizona, 85013, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Pharmacology Research Institute
Northridge, California, 91324, United States
UCI Medical Center
Orange, California, 92868, United States
Pacific Research Network
San Diego, California, 92103, United States
Affiliated Research Institute
San Diego, California, 92108, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, 33321, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410, United States
Neurology Clinical Research, Inc.
Plantation, Florida, 33324, United States
University of South Florida
Tampa, Florida, 33612, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Indiana Universisty Medical Center
Indianapolis, Indiana, 46202, United States
Lexington Clinic
Lexington, Kentucky, 40504, United States
J. Gary Booker, MD
Shreveport, Louisiana, 71101, United States
Mood and Memory Clinic of Michigan
Farmington Hills, Michigan, 48334, United States
St. Louis University
St Louis, Missouri, 63104, United States
Alzheimer's Research Corporation
Lakehurst, New Jersey, 08733, United States
Joel Ross, MD
Long Branch, New Jersey, 07740, United States
Ubhc/Umdnj
Piscataway, New Jersey, 08855, United States
Upstate Clinical Research
Albany, New York, 12205, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, 10962, United States
Monroe Community Hospital
Rochester, New York, 14620, United States
Behavioral Medical Research of Saten Island, PC
Staten Island, New York, 10305, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Ohio State University
Columbus, Ohio, 443210, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Summit Research Network
Portland, Oregon, 97223, United States
Medical University of South Carolina
Charleston, South Carolina, 29406, United States
North Texas Neurology Research
Wichita, Texas, 76301, United States
Pioneer Pharmaceutical Research
Midvale, Utah, 84047, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 24, 2004
First Posted
August 26, 2004
Study Start
March 1, 2003
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
March 5, 2012
Record last verified: 2012-03