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Memantine for Agitation and Aggression in Severe Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
memantine
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, behavioral and psychological symptoms of dementia, severe Alzheimer's disease, memantine, agitation, aggression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North York General Hospital
  • Sunnybrook Health Sciences Centre

Outcomes

Primary Outcome Measures

Neuropsychiatric Inventory Nursing Home Version
Clinical Global Impression of Change

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2006
Last Updated
May 24, 2012
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Lundbeck Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00401167
Brief Title
Memantine for Agitation and Aggression in Severe Alzheimer's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Lundbeck Canada Inc.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, behavioral and psychological symptoms of dementia, severe Alzheimer's disease, memantine, agitation, aggression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
memantine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory Nursing Home Version
Time Frame
Screening, Baseline, 1 month, 2 months, 3 months
Title
Clinical Global Impression of Change
Time Frame
Baseline, 1 month, 2 months, 3 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory Nursing Home Version
Time Frame
Screening, baseline, 1 month, 2 months, 3 months
Title
Neuropsychiatric Inventory Burden Subscale
Time Frame
Screening, baseline, 1 month, 2 months, 3 months
Title
Cohen Mansfield Agitation Inventory
Time Frame
Baseline, 1 month, 2 months, 3 months
Title
Modified Nursing Care Assessment Scale
Time Frame
Baseline, 3 months
Title
Activities of Daily Living
Time Frame
Baseline, 3 months
Title
Quality of Life in Late Stage Dementia
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Herrmann, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21476613
Citation
Herrmann N, Cappell J, Eryavec GM, Lanctot 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.
Results Reference
derived

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Memantine for Agitation and Aggression in Severe Alzheimer's Disease

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