Memantine for Agitation and Aggression in Severe Alzheimer's Disease
Alzheimer's disease (AD) is the most common form of dementia and is characterized by both cognitive and behavioural symptoms ("Behavioural and Psychological Symptoms of Dementia"; BPSD). To date, there are only modestly effective treatments for BPSD, and these treatments are associated with an increased risk of mortality in elderly dementia patients. We plan to study whether treatment with medication memantine improves BPSD in severe AD patients. Thirty-two AD patients with significant BPSD, including agitation and aggression, will be treated for three months with memantine. Assessments of behavioural symptoms and global clinical outcomes will be completed after one, two and three months of treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Neuropsychiatric Inventory Nursing Home Version [ Time Frame: Screening, Baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change [ Time Frame: Baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory Nursing Home Version [ Time Frame: Screening, baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory Burden Subscale [ Time Frame: Screening, baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Cohen Mansfield Agitation Inventory [ Time Frame: Baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]
- Modified Nursing Care Assessment Scale [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
- Activities of Daily Living [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
- Quality of Life in Late Stage Dementia [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401167
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|North York General Hospital|
|Toronto, Ontario, Canada, M2K 1E1|
|Principal Investigator:||Nathan Herrmann, MD||Sunnybrook Health Sciences Centre|