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

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ClinicalTrials.gov Identifier: NCT00334906
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : January 7, 2008
Sponsor:
Information provided by:
Forest Laboratories

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: memantine HCl Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2005
Actual Primary Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy
  2. Total brain atrophy on MRI

Secondary Outcome Measures :
  1. 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
  2. Safety

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334906


Locations
United States, New Jersey
Forest Laboratories
Jersey City, New Jersey, United States, 07311
Sponsors and Collaborators
Forest Laboratories
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00334906     History of Changes
Other Study ID Numbers: MEM-MD-15
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Keywords provided by Forest Laboratories:
memantine
Alzheimer's disease
MRI
moderate Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents