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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00090116
Enrollment
400
Registered
2004-08-26
Start date
2003-03-31
Completion date
2005-03-31
Last updated
2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease

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).

Interventions

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026