Phase 3
N=677
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Dementia of the Alzheimer's Type
Bottom Line
View on ClinicalTrials.gov: NCT00322153 ↗Enrolled (actual)
677
Serious AEs
7.2%
Results posted
Sep 2010
Primary outcome: Primary: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) — -0.4; 2.2 Units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- memantine ER (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) |
-0.4; 2.2 | 0.001 sig |
| PRIMARY Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) |
4.1; 3.8 | 0.008 sig |
| SECONDARY Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) |
-1.7; -1.0 | 0.177 |
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
Data sourced from ClinicalTrials.gov (NCT00322153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.