Memantine on Aggression and Agitation of Alzheimer's Disease (AD)

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: NCT00703430
Recruitment Status : Unknown
Verified January 2013 by Xin Yu, Peking University.
Recruitment status was:  Recruiting
First Posted : June 23, 2008
Last Update Posted : January 25, 2013
H. Lundbeck A/S
Information provided by (Responsible Party):
Xin Yu, Peking University

Brief Summary:
Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of AD patients in Beijing. Agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized treatment for Alzheimer's disease either alone or in combination with cholinesterase inhibitors. Its efficacy in vascular dementia is also established. Family members continue to play a central role in home care for the demented elderly in China. This proposal is to conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the treatment of agitation and aggression in AD patients. In addition, this proposal aims to explore the impact of memantine on caregiver burden of AD patients in Chinese culture.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Memantine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Memantine on Aggression and Agitation and Its Impact on Caregiver Burden of Patients With Alzheimer's Disease: A 12-week Open-label Study
Study Start Date : March 2008
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: 1
Drug: Memantine
Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.
Other Name: Ebixa®

Primary Outcome Measures :
  1. CMAI score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. CBI score [ Time Frame: 12 weeks ]
  2. RUD [ Time Frame: 12 weeks ]
  3. NPI score [ Time Frame: 12 weeks ]

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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:

  1. Written informed consent
  2. Clinical diagnosis of Alzheimer's disease.
  3. Having at least a minimum aggression score on the Cohen-Mansfield Agitation Inventory (CMAI): a score of ≥ 4 on at least 1 aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3.
  4. Availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments.

Exclusion Criteria:

  1. Unavailability of a responsible family member or carer
  2. Severe renal impairment.
  3. History of seizures
  4. Diagnosis of any concomitant life threatening illness.

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): NCT00703430

Contact: Huali Wang, MD, PhD +86-10-82801983

Peking University Institute of Mental Health Recruiting
Beijing, China, 100083
Contact: Huali Wang, MD, PhD    +86-10-82801983   
Principal Investigator: Huali Wang, MD, PhD         
Sub-Investigator: Tao Li, MD         
Sponsors and Collaborators
Peking University
H. Lundbeck A/S
Principal Investigator: Xin Yu, MD Peking University Institute of Mental Health

Responsible Party: Xin Yu, Institute Director, Peking University Identifier: NCT00703430     History of Changes
Other Study ID Numbers: CN-IIT-12292
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Keywords provided by Xin Yu, Peking University:
Alzheimer's disease, agitation, aggression, dementia

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Behavioral Symptoms
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