CompletedPhase 3

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

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

Lead sponsor

Forest Laboratories

Asset

Neramexane

Listed sites

Recruiting sites

Enrollment

400

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00090116

Org study IDNER-MD-02

Timeline

Milestones

Study start2003-03 (month precision)

Study first posted2004-08-26estimated

Primary completion2005-03actual (month precision)

Study completion2005-03actual (month precision)

Last update posted2012-03-05estimated

Assets

Drug assets

Neramexane

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.