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

This study has been completed.
Information provided by:
Forest Laboratories Identifier:
First received: August 24, 2004
Last updated: March 1, 2012
Last verified: March 2012
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Estimated Enrollment: 400
Study Start Date: March 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00090116

  Show 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information Identifier: NCT00090116     History of Changes
Other Study ID Numbers: NER-MD-02
Study First Received: August 24, 2004
Last Updated: March 1, 2012

Keywords provided by Forest Laboratories:
NMDA receptor antagonist
Memory Loss
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on September 18, 2017