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Sponsors and Collaborators: |
Peking University H. Lundbeck A/S |
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Information provided by: | Peking University |
ClinicalTrials.gov Identifier: | NCT00703430 |
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.
Condition | Intervention |
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Alzheimer's Disease |
Drug: Memantine |
Study Type: | Interventional |
Study Design: | Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Memantine
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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.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Huali Wang, MD, PhD | +86-10-82801983 | dcrctraining@gmail.com |
China | |
Peking University Institute of Mental Health | Recruiting |
Beijing, China, 100083 | |
Contact: Huali Wang, MD, PhD +86-10-82801983 dcrctraining@gmail.com | |
Principal Investigator: Huali Wang, MD, PhD | |
Sub-Investigator: Tao Li, MD |
Principal Investigator: | Xin Yu, MD | Peking University Institute of Mental Health |
Responsible Party: | Peking University Institute of Mental Health ( Xin Yu ) |
Study ID Numbers: | CN-IIT-12292 |
Study First Received: | June 20, 2008 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00703430 History of Changes |
Health Authority: | China: Ethics Committee |
Alzheimer's disease, agitation, aggression, dementia |
Excitatory Amino Acids Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Psychomotor Agitation Brain Diseases Neurodegenerative Diseases Cognition Disorders Behavioral Symptoms |
Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Memantine Dopamine Agents Dementia Aggression Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Excitatory Amino Acid Agents Brain Diseases Neurodegenerative Diseases Pharmacologic Actions |
Behavioral Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Memantine Dopamine Agents Aggression Dementia Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |