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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00703430
• Other study ID #: CN-IIT-12292
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2008
• Last updated: January 24, 2013
• Start date: March 2008
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Peking University
• Contact: Huali Wang, MD, PhD
• Phone: +86-10-82801983
• Email: dcrctraining[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Institute of Mental Health	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMAI score		12 weeks	No
Secondary	CBI score		12 weeks	No
Secondary	RUD		12 weeks	No
Secondary	NPI score		12 weeks	No