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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703430

Enrollment

Registered

2008-06-23

Start date

2008-03-31

Completion date

2014-06-30

Last updated

2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, agitation, aggression, dementia

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.

Interventions

DRUGMemantine

Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
CMAI score	12 weeks

Secondary

Measure	Time frame
CBI score	12 weeks
RUD	12 weeks
NPI score	12 weeks

Countries

China

Contacts

Primary ContactHuali Wang, MD, PhD

dcrctraining@gmail.com+86-10-82801983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026