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Clinical Trial Details

NCT ID: NCT00703430
Date Last Changed: January 24, 2013

Overview

Research Study Summary

A clinical trial to evaluate treatments using Memantine for patients with Alzheimer's Disease

Research Study 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

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.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
50 and up
Overall Status
Recruiting
Lead Sponsor
Peking University
Duration
69 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 50 Years and up

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.

Site Locations (1)

Country State City Zip Facility and Contact
China Beijing 100083 Peking University Institute of Mental Health
Huali Wang, MD, PhD
+86-10-82801983
dcrctraining@gmail.com

Huali Wang, MD, PhD
Principal Investigator

Tao Li, MD
Sub-Investigator

Contact

Huali Wang, MD, PhD
+86-10-82801983
E-mail:

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