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

This study is currently recruiting participants.
Verified January 2013 by Peking University
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Xin Yu, Peking University
ClinicalTrials.gov Identifier:
NCT00703430
First received: June 20, 2008
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CBI score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • RUD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • NPI score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Memantine
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®

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703430

Contacts
Contact: Huali Wang, MD, PhD +86-10-82801983 dcrctraining@gmail.com

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

No publications provided

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

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

Additional relevant MeSH terms:
Aggression
Alzheimer Disease
Psychomotor Agitation
Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014