Status:
COMPLETED
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Lead Sponsor:
Forest Laboratories
Conditions:
Dementia of the Alzheimer's Type
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for th...
Eligibility Criteria
Inclusion
- 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 and \</= 14 at Screening (Visit 1) and 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
677 Patients enrolled
Trial Details
Trial ID
NCT00322153
Start Date
June 1 2005
End Date
January 1 2008
Last Update
September 16 2010
Active Locations (83)
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1
Forest Investigative Site 010
Phoenix, Arizona, United States, 85004
2
Forest Investigative Site 062
Costa Mesa, California, United States, 92626
3
Forest Investigative Site 050
Fresno, California, United States, 93720
4
Forest Investigative Site 024
San Francisco, California, United States, 94118