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

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

This study has been completed.

Study NCT00322153. Last updated on January 3, 2008. Information provided by Forest Laboratories

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Official Title ^†	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type
Brief Summary	The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients with moderate-to-severe Alzheimer's disease on a concurrent acetylcholinesterase inhibitor (AChEI).
Detailed Description	Memantine is a novel therapeutic agent that represents a new class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	Severe Impairment Battery (SIB) Clinician's Interview Based Impression of Change - Plus Version (CIBIC-Plus)
Secondary Outcome Measure ^†	Neuropsychiatric Inventory (NPI) Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Condition ^†	Alzheimer's Disease
Intervention ^†	Drug: memantine HCL
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	600
Start Date ^†	June 2005
Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Healthy, ambulatory patients aged >/= 50 years Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria 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 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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00322153
Organization ID	MEM-MD-50
Secondary IDs ^††
Study Sponsor ^†	Forest Laboratories
Collaborators ^††
Investigators ^†
Information Provided By	Forest Laboratories
Verification Date	January 2008
First Received Date ^†	May 3, 2006
Last Updated Date	January 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.