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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
History of Changes
  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 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401167

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Lundbeck Canada Inc.
Investigators
Principal Investigator: Nathan Herrmann, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00401167     History of Changes
Other Study ID Numbers: Lundbeck-11267
Study First Received: November 16, 2006
Last Updated: May 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Alzheimer's disease
behavioral and psychological symptoms of dementia
severe Alzheimer's disease
 memantine
agitation
aggression

Additional relevant MeSH terms:
Aggression
Alzheimer Disease
Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013