Memantine for Agitation and Aggression in Severe Alzheimer's Disease

January 29, 2024 updated by: Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychiatric Inventory Nursing Home Version
Time Frame: Screening, Baseline, 1 month, 2 months, 3 months
Screening, Baseline, 1 month, 2 months, 3 months
Clinical Global Impression of Change
Time Frame: Baseline, 1 month, 2 months, 3 months
Baseline, 1 month, 2 months, 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychiatric Inventory Nursing Home Version
Time Frame: Screening, baseline, 1 month, 2 months, 3 months
Screening, baseline, 1 month, 2 months, 3 months
Neuropsychiatric Inventory Burden Subscale
Time Frame: Screening, baseline, 1 month, 2 months, 3 months
Screening, baseline, 1 month, 2 months, 3 months
Cohen Mansfield Agitation Inventory
Time Frame: Baseline, 1 month, 2 months, 3 months
Baseline, 1 month, 2 months, 3 months
Modified Nursing Care Assessment Scale
Time Frame: Baseline, 3 months
Baseline, 3 months
Activities of Daily Living
Time Frame: Baseline, 3 months
Baseline, 3 months
Quality of Life in Late Stage Dementia
Time Frame: Baseline, 3 months
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Lundbeck Canada Inc.

Investigators

  • Principal Investigator: Nathan Herrmann, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (Estimated)

November 17, 2006

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lundbeck-11267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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