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| Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre H. Lundbeck A/S |
|---|---|
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00401167 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: memantine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 32 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | August 2008 |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Krista Lanctot, PhD | 416-480-6100 ext 2241 | krista.lanctot@sunnybrook.ca |
| Contact: Ryan Rajaram, MSc | 416-480-6100 ext 3185 | ryan.rajaram@sri.utoronto.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Ryan Rajaram, MSc 416-480-6100 ext 3185 ryan.rajaram@sri.utoronto.ca | |
| Principal Investigator: Nathan Herrmann, MD | |
| Sub-Investigator: Krista Lanctot, PhD | |
| North York General Hospital | Recruiting |
| Toronto, Ontario, Canada, M2K 1E1 | |
| Contact: Goran Eryavec, MD 416-756-6050 ext 8057 geryavec@nygh.on.ca | |
| Principal Investigator: Goran Eryavec, MD | |
| Principal Investigator: | Nathan Herrmann, MD | Sunnybrook Health Sciences Centre |
More Information
| Study ID Numbers: | Lundbeck-11267 |
| Study First Received: | November 16, 2006 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00401167 |
| Health Authority: | Canada: Health Canada |
|
Alzheimer's disease behavioral and psychological symptoms of dementia severe Alzheimer's disease |
memantine agitation aggression |
|
Excitatory Amino Acids Alzheimer Disease Central Nervous System Diseases Psychomotor Agitation Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Dopamine Mental Disorders Memantine Dementia Aggression Delirium |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents |
Pharmacologic Actions Therapeutic Uses Dopamine Agents Tauopathies Central Nervous System Agents Excitatory Amino Acid Antagonists |
