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

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00322153

Purpose

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).

Condition	Intervention	Phase
Alzheimer's Disease	Drug: memantine HCL	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Severe Impairment Battery (SIB)
Clinician's Interview Based Impression of Change - Plus Version (CIBIC-Plus)

Secondary Outcome Measures:

Neuropsychiatric Inventory (NPI)
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)

Estimated Enrollment:	600
Study Start Date:	June 2005
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322153

Locations

United States, Missouri
For information regarding investigative sites please contact Forest Professional Affairs
St. Louis, Missouri, United States, 63045

Sponsors and Collaborators

Forest Laboratories

More Information

Study ID Numbers:	MEM-MD-50
Study First Received:	May 3, 2006
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00322153
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

memantine
Alzheimer's disease
moderate to severe Alzheimer's disease

Study placed in the following topic categories:

Excitatory Amino Acids
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Memantine

Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents

Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Tauopathies
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 14, 2009