Alzheimer's Disease | Memantine on Aggression and Agitation of Alzheimer's Disease (AD)
Alzheimer's Disease research study
What is the primary objective of this 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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MemantineInitially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2008
Completed Date: June 2014
Primary Outcome: CMAI score
Secondary Outcome: CBI score
Study sponsors, principal investigator, and references
Principal Investigator: Xin Yu, MD
Lead Sponsor: Peking University
Collaborator: H. Lundbeck A/S