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

This study has been completed.

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00090116

Purpose

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).

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Neramexane	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

Drug Information available for: Neramexane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Forest Laboratories:

Estimated Enrollment:	400
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090116

Show 36 Study Locations

Sponsors and Collaborators

Forest Laboratories

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	NER-MD-02
Study First Received:	August 24, 2004
Last Updated:	February 14, 2006
ClinicalTrials.gov Identifier:	NCT00090116
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Neramexane
NMDA receptor antagonist
Memory Loss
Alzheimer Disease

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Amnesia
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009