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

About this trial
This is an interventional treatment trial for Dementia of the Alzheimer's Type focused on measuring memantine, Alzheimer's disease, moderate to severe Alzheimer's disease
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
Sites / Locations
- Forest Investigative Site 010
- Forest Investigative Site 062
- Forest Investigative Site 050
- Forest Investigative Site 024
- Forest Investigative Site 071
- Forest Investigative Site 002
- Forest Investigative Site 021
- Forest Investigative Site 052
- Forest Investigative Site 070
- Forest Investigative Site 065
- Forest Investigative Site 043
- Forest Investigative Site 044
- Forest Investigative Site 001
- Forest Investigative Site 034
- Forest Investigative Site 068
- Forest Investigative Site 038
- Forest Investigative Site 008
- Forest Investigative Site 028
- Forest Investigative Site 009
- Forest Investigative Site 069
- Forest Investigative Site 045
- Forest Investigative Site 014
- Forest Investigative Site 064
- Forest Investigative Site 011
- Forest Investigative Site 003
- Forest Investigative Site 048
- Forest Investigative Site 006
- Forest Investigative Site 004
- Forest Investigative Site 027
- Forest Investigative Site 012
- Forest Investigative Site 020
- Forest Investigative Site 032
- Forest Investigative Site 018
- Forest Investigative Site 067
- Forest Investigative Site 041
- Forest Investigative Site 017
- Forest Investigative Site 013
- Forest Investigative Site 026
- Forest Investigative Site 103
- Forest Investigative Site 105
- Forest Investigative Site 123
- Forest Investigative Site 113
- Forest Investigative Site 102
- Forest Investigative Site 118
- Forest Investigative Site 109
- Forest Investigative Site 104
- Forest Investigative Site 108
- Forest Investigative Site 114
- Forest Investigative Site 106
- Forest Investigative Site 119
- Forest Investigative Site 122
- Forest Investigative Site 107
- Forest Investigative Site 111
- Forest Investigative Site 121
- Forest Investigative Site 115
- Forest Investigative Site 116
- Forest Investigative Site 112
- Forest Investigative Site 124
- Forest Investigative Site 110
- Forest Investigative Site 125
- Forest Investigative Site 120
- Forest Investigative Site 308
- Forest Investigative Site 301
- Forest Investigative Site 309
- Forest Investigative Site 303
- Forest Investigative Site 310
- Forest Investigative Site 313
- Forest Investigative Site 305
- Forest Investigative Site 302
- Forest Investigative Site 304
- Forest Investigative Site 312
- Forest Investigative Site 306
- Forest Investigative Site 212
- Forest Investigative Site 202
- Forest Investigative Site 207
- Forest Investigative Site 211
- Forest Investigative Site 205
- Forest Investigative Site 203
- Forest Investigative Site 208
- Forest Investigative Site 204
- Forest Investigative Site 213
- Forest Investigative Site 206
- Forest Investigative Site 210
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Memantine ER
Oral administration, once daily.
28mg, once daily. Oral administration for 24 weeks.