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Memantine for Agitation and Aggression in Severe Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Canada Inc.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00401167
First received: November 16, 2006
Last updated: May 24, 2012
Last verified: January 2010

November 16, 2006
May 24, 2012
November 2006
January 2010   (final data collection date for primary outcome measure)
  • 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
  • Clinical Global Impression of Change
Complete list of historical versions of study NCT00401167 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Neuropsychiatric Inventory Nursing Home Version
  • Neuropsychiatric Inventory Burden Subscale
  • Cohen Mansfield Agitation Inventory
  • Modified Nursing Care Assessment Scale
  • Activities of Daily Living
  • Quality of Life in Late Stage Dementia
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
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.
Not Provided
Herrmann N, Cappell J, Eryavec GM, Lanctôt KL. Changes in nursing burden following memantine for agitation and aggression in long-term care residents with moderate to severe Alzheimer's disease: an open-label pilot study. CNS Drugs. 2011 May;25(5):425-33. doi: 10.2165/11588160-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00401167
Lundbeck-11267
Not Provided
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Lundbeck Canada Inc.
Principal Investigator: Nathan Herrmann, MD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP