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

Forest Laboratories34 sites in 1 country400 target enrollmentMarch 2003

ConditionsAlzheimer's Disease

DrugsNeramexane

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Forest Laboratories
Enrollment: 400
Locations: 34
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

March 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

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