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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Peking University.
Recruitment status was:  Recruiting
H. Lundbeck A/S
Information provided by (Responsible Party):
Xin Yu, Peking University Identifier:
First received: June 20, 2008
Last updated: January 24, 2013
Last verified: January 2013
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 Intervention
Alzheimer's Disease
Drug: Memantine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Peking University:

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

Secondary Outcome Measures:
  • CBI score [ Time Frame: 12 weeks ]
  • RUD [ Time Frame: 12 weeks ]
  • NPI score [ Time Frame: 12 weeks ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Xin Yu, Institute Director, Peking University Identifier: NCT00703430     History of Changes
Other Study ID Numbers: CN-IIT-12292
Study First Received: June 20, 2008
Last Updated: January 24, 2013

Keywords provided by 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
Behavioral Symptoms
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and 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 processed this record on April 26, 2017