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An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097916
Recruitment Status : Completed
First Posted : December 2, 2004
Last Update Posted : March 5, 2012
Information provided by:
Forest Laboratories

Brief Summary:
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: memantine HCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease
Study Start Date : September 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Primary Outcome Measures :
  1. Neuropsychiatric Inventory

Secondary Outcome Measures :
  1. Cohen Mansfield Agitation Inventory
  2. Clinical Global Impression Scale
  4. Agitation/aggression domain of Neuropsychiatric Inventory (NPI)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI
  • Stable dose of donepezil for 3 months

Exclusion Criteria:

  • Other evidence of psychiatric disorders
  • Oncologic diagnosis
  • Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Information from the National Library of Medicine

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 identifier (NCT number): NCT00097916

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United States, California
The Forves Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
Coastal Communities Hospital
Westminster, California, United States, 92683
United States, Connecticut
Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
United States, Florida
Berma Research Group
Hialeah, Florida, United States, 33016
Baumel-Eisner Neuromedical Institute
Miami, Florida, United States, 33154
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Hawaii
Geriatric Medicine
Honolulu, Hawaii, United States, 96817
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Forest Laboratories
Layout table for additonal information Identifier: NCT00097916    
Other Study ID Numbers: MEM-MD-23
First Posted: December 2, 2004    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Forest Laboratories:
memantine HCl
Alzheimer Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
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