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

NCT00703430 | Unknown DMC

• 1 other identifier: CN-IIT-12292
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, agitation, aggression, dementia

Outcome Measures

Primary Outcomes (1)

• CMAI score

  12 weeks

Secondary Outcomes (3)

• CBI score

  12 weeks

• RUD

  12 weeks

• NPI score

  12 weeks

Study Arms (1)

1

EXPERIMENTAL

Memantine

Drug: Memantine

Interventions

Memantine DRUG

Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.

Also known as: Ebixa®

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Peking University Institute of Mental Health

Beijing, 100083, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Aggression; Dementia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xin Yu, MD

  Peking University Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huali Wang, MD, PhD

CONTACT

+86-10-82801983; dcrctraining@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Director

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

CN (1)