Clinical trial NCT00090116: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Neramexane
NMDA receptor antagonist
Memory Loss
Alzheimer Disease
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2004-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

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