- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00401167
Memantine for Agitation and Aggression in Severe Alzheimer's Disease
Phase IV-An Open-Label Prospective Study of Memantine in Institutionalized Patients With Severe Alzheimer's Disease and Significant Behavioural and Psychological Symptoms of Dementia
Study Overview
Detailed Description
BPSD in institutionalized patients with severe AD is a serious public health problem. The effectiveness of current pharmacological management of BPSD with atypical antipsychotics is modest at best, and there are serious safety concerns including increased cerebrovascular adverse events and increased mortality. Preliminary data with memantine suggests this medication may be helpful for treating BPSD in the severe subgroup of the Alzheimer's disease patient population. It is for this reason we propose an open-label prospective study of memantine in institutionalized patients with severe Alzheimer's disease and significant BPSD.
The major objective of this study is to examine the effectiveness of memantine on behaviour with a focus on agitation and aggression. The secondary objective is to determine the effect of memantine on nursing burden and prescription medication use. The study would expand clinical experience with memantine and provide information on professional caregiver burden and prescription medication use in this institutionalized, more severely impaired and frailer population. This information could be used to design a randomized placebo controlled confirmatory trial.
The effectiveness of memantine on agitation and aggression in patients with moderate to severe Alzheimer's disease will be assessed in a 3-month, open-label study involved 32 patients residing in long-term care facilities.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed informed consent obtained from a legally acceptable representative
- Male or female > 65 years of age, residing in long-term care
- Diagnosis and Statistical Manual of Mental Disorders (DSM-IV-TR) diagnosis of Dementia of the Alzheimer's type (code 290.1)
- Mini Mental State Examination total score ≤ 15
- Neuropsychiatric Inventory-Nursing Home Version total score > 10, and a score > 1 on the agitation/aggression subscale
- A current order for any prescription medication for behavioral and psychological symptoms of dementia (e.g. benzodiazepine, antipsychotic, trazodone), with at least 1 dose used in the prior 3 months
- Patients with a current order for any regularly administered psychotropic (example, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, trazodone, atypical antipsychotics, typical antipsychotics or cholinesterase inhibitors) must have been on a stable dose for 3 months prior to entry
Exclusion Criteria:
- Current evidence of any uncontrolled medical illness that would interfere with the subject's participation in the study
- Dementia due to any etiology other than Alzheimer's Disease
- Subjects experiencing significant difficulties ingesting oral medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychiatric Inventory Nursing Home Version
Time Frame: Screening, Baseline, 1 month, 2 months, 3 months
|
Screening, Baseline, 1 month, 2 months, 3 months
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Clinical Global Impression of Change
Time Frame: Baseline, 1 month, 2 months, 3 months
|
Baseline, 1 month, 2 months, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuropsychiatric Inventory Nursing Home Version
Time Frame: Screening, baseline, 1 month, 2 months, 3 months
|
Screening, baseline, 1 month, 2 months, 3 months
|
Neuropsychiatric Inventory Burden Subscale
Time Frame: Screening, baseline, 1 month, 2 months, 3 months
|
Screening, baseline, 1 month, 2 months, 3 months
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Cohen Mansfield Agitation Inventory
Time Frame: Baseline, 1 month, 2 months, 3 months
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Baseline, 1 month, 2 months, 3 months
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Modified Nursing Care Assessment Scale
Time Frame: Baseline, 3 months
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Baseline, 3 months
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Activities of Daily Living
Time Frame: Baseline, 3 months
|
Baseline, 3 months
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Quality of Life in Late Stage Dementia
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nathan Herrmann, MD, Sunnybrook Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Aggression
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- Lundbeck-11267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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