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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dementia of the Alzheimer's Type

In brief

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).

Key facts

Study ID

NCT00322153

Run by

Forest Laboratories

People needed

677

Starts

2005-06-01

Expected to finish

2008-01-01

Last updated by the study team

2010-09-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 062 — Costa Mesa, California, United States
• Forest Investigative Site 050 — Fresno, California, United States
• Forest Investigative Site 024 — San Francisco, California, United States
• Forest Investigative Site 071 — Santa Ana, California, United States
• Forest Investigative Site 002 — Denver, Colorado, United States
• Forest Investigative Site 021 — Boca Raton, Florida, United States
• Forest Investigative Site 052 — Boynton Beach, Florida, United States
• Forest Investigative Site 070 — Delray Beach, Florida, United States
• Forest Investigative Site 065 — Fort Myers, Florida, United States
• Forest Investigative Site 043 — Hallandale, Florida, United States
• Forest Investigative Site 044 — Hallandale, Florida, United States
• Forest Investigative Site 001 — Miami, Florida, United States
• Forest Investigative Site 034 — North Miami, Florida, United States
• Forest Investigative Site 068 — Orlando, Florida, United States
• Forest Investigative Site 038 — Palm Beach Gardens, Florida, United States
• Forest Investigative Site 008 — St. Petersburg, Florida, United States
• Forest Investigative Site 028 — Tampa, Florida, United States
• Forest Investigative Site 009 — Snellville, Georgia, United States
• Forest Investigative Site 069 — Joliet, Illinois, United States
• Forest Investigative Site 045 — Kalamazoo, Michigan, United States
• Forest Investigative Site 014 — Saint Loius, Missouri, United States
• Forest Investigative Site 064 — Long Branch, New Jersey, United States
• Forest Investigative Site 011 — Morristown, New Jersey, United States
• Forest Investigative Site 003 — New Brunswick, New Jersey, United States
• Forest Investigative Site 010 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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