Memantine for Agitation and Aggression in Severe Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00401167|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: memantine||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Drug: memantine
Following the baseline visit, subjects will receive memantine 5 mg OD for one week, followed by 5 mg BID for one week, followed by 10 mg QAM and 5 mg QPM for one week, followed by 10 mg BID for the following 9 weeks.
- Neuropsychiatric Inventory Nursing Home Version [ Time Frame: Screening, Baseline, 1 month, 2 months, 3 months ]
- Clinical Global Impression of Change [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
- Neuropsychiatric Inventory Nursing Home Version [ Time Frame: Screening, baseline, 1 month, 2 months, 3 months ]
- Neuropsychiatric Inventory Burden Subscale [ Time Frame: Screening, baseline, 1 month, 2 months, 3 months ]
- Cohen Mansfield Agitation Inventory [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
- Modified Nursing Care Assessment Scale [ Time Frame: Baseline, 3 months ]
- Activities of Daily Living [ Time Frame: Baseline, 3 months ]
- Quality of Life in Late Stage Dementia [ Time Frame: Baseline, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401167
|North York General Hospital|
|Toronto, Ontario, Canada, M2K 1E1|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Nathan Herrmann, MD||Sunnybrook Health Sciences Centre|