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

Tracking Information
First Received Date ^ICMJE	May 3, 2006
Last Updated Date	January 3, 2008
Start Date ^ICMJE	June 2005
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2006)	Severe Impairment Battery (SIB) Clinician's Interview Based Impression of Change - Plus Version (CIBIC-Plus)
Original Primary Outcome Measures ^ICMJE (submitted: May 4, 2006)	Sever Impairment Battery (SIB) Clinician's Interview Based Impression of Change - Plus Version (CIBIC-Plus)
Change History	Complete list of historical versions of study NCT00322153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 4, 2006)	Neuropsychiatric Inventory (NPI) Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: memantine HCL
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00322153
Responsible Party
Study ID Numbers ^ICMJE	MEM-MD-50
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Forest Laboratories
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP