Memantine on Aggression and Agitation of Alzheimer's Disease (AD) - Full Text View

Sponsors and Collaborators:	Peking University H. Lundbeck A/S
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00703430

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

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
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

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 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

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

Criteria

Inclusion Criteria:

Written informed consent
Clinical diagnosis of Alzheimer's disease.
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.
Availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments.

Exclusion Criteria:

Unavailability of a responsible family member or carer
Severe renal impairment.
History of seizures
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

Responsible Party:	Peking University Institute of Mental Health ( Xin Yu )
Study ID Numbers:	CN-IIT-12292
Study First Received:	June 20, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703430
Health Authority:	China: Ethics Committee

Keywords provided by Peking University:

Alzheimer's disease, agitation, aggression, dementia

Study placed in the following topic categories:

Excitatory Amino Acids
Alzheimer Disease
Central Nervous System Diseases
Psychomotor Agitation
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Behavioral Symptoms

Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dementia
Aggression
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents

Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Tauopathies
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 15, 2009