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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00090116
First received: August 24, 2004
Last updated: March 1, 2012
Last verified: March 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)
  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 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00090116     History of Changes
Other Study ID Numbers: NER-MD-02
Study First Received: August 24, 2004
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014