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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014