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”

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.

Study Type: Interventional

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

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Memantine

Primary Measures

• CMAI score
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• CBI score
  • Time Frame: 12 weeks
    Safety Issue?: No
• RUD
  • Time Frame: 12 weeks
    Safety Issue?: No
• NPI score
  • Time Frame: 12 weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Peking University

Overall Clinical Trial Officials and Contacts

Xin Yu, MD Principal Investigator Peking University Institute of Mental Health  

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00703430

Study ID Number: CN-IIT-12292

ClinicalTrials.gov Identifier: NCT00703430

Health Authority: China: Ethics Committee