Back to resultsMemantine on Aggression and Agitation of Alzheimer's Disease (AD)
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Memantine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, agitation, aggression, dementia
Eligibility 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.
Sites / Locations
- Peking University Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Memantine
Outcomes
Primary Outcome Measures
CMAI score
Secondary Outcome Measures
CBI score
RUD
NPI score
Full Information
NCT ID
NCT00703430
First Posted
June 20, 2008
Last Updated
January 24, 2013
Sponsor
Peking University
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00703430
Brief Title
Memantine on Aggression and Agitation of Alzheimer's Disease (AD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, agitation, aggression, dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Memantine
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Ebixa®
Intervention Description
Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.
Primary Outcome Measure Information:
Title
CMAI score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
CBI score
Time Frame
12 weeks
Title
RUD
Time Frame
12 weeks
Title
NPI score
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huali Wang, MD, PhD
Phone
+86-10-82801983
Email
dcrctraining@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Yu, MD
Organizational Affiliation
Peking University Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Mental Health
City
Beijing
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huali Wang, MD, PhD
Phone
+86-10-82801983
Email
dcrctraining@gmail.com
First Name & Middle Initial & Last Name & Degree
Huali Wang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tao Li, MD
12. IPD Sharing Statement
Learn more about this trial
Memantine on Aggression and Agitation of Alzheimer's Disease (AD)
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