A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Condition: Dementia of the Alzheimer's Type
MeSH terms: Alzheimer Disease; Dementia
Intervention: memantine ER; Placebo
Intervention description: 28mg(7mg capsules) once daily and oral administration for 24 weeks.; Matching placebo oral administration once daily.
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 677.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: memantine; Alzheimer's disease; moderate to severe Alzheimer's disease

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).
    

Eligibility 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 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 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