Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease) - Full Text View

Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

This study has been completed.

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00334906

Purpose

The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: memantine HCl	Phase IV

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Dementia

ChemIDplus related topics:

Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Efficacy
Total brain atrophy on MRI

Secondary Outcome Measures:

Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
Safety

Estimated Enrollment:	75
Study Start Date:	July 2005
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive]
On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion Criteria:

Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
Previous imaging results not consistent with the diagnosis of AD
Modified Hachinski Ischemia Score greater than 4
Evidence of other neurologic disorders
Inability to participate in MRI testing
No clinically significant systemic disease
A known or suspected history of alcohol or drug abuse in the past 10 years
Taking excluded medication
Previous treatment with commercial memantine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334906

Locations


United States, New Jersey
	Forest Laboratories
	Jersey City, New Jersey, United States, 07311

Sponsors and Collaborators

Forest Laboratories

More Information

Study ID Numbers:	MEM-MD-15
First Received:	June 6, 2006
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00334906
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

memantine

Alzheimer's disease

MRI

moderate 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 October 14, 2008