A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Ambulatory patients aged >/= 50 years

• Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

• Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.

• Mini-Mental State Examination (MMSE) scores >/= 3 andand Baseline (Visit 2)

• Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

• Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.

• Patients who have taken memantine within one month of Screening (Visit 1)

• Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.

• Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.

• Patients who are receiving therapy with more than one AChEI.

• Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.

• Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.

• Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.

• Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years

• Patients who had dementia that was complicated by other organic disease

• Patients who had dementia complicated by the presence of predominant delusions