Completed

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

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What is being tested

Data Collection

Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2003
See protocol details

Summary

Principal SponsorForest Laboratories
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2003

Actual date on which the first participant was enrolled.

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).

Official TitleA 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 
NCT00090116
Principal SponsorForest Laboratories
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 35 locations

Suspended

Pivotal Research Centers

Peoria, United StatesSee the location
Suspended

21st Century Neurology

Phoenix, United States
Suspended

Margolin Brain Institute

Fresno, United States
Suspended

Pharmacology Research Institute

Northridge, United States
Completed35 Study Centers