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NCT Number: NCT00401167

Memantine for Agitation and Aggression in Severe Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Aberrant Motor Behavior in Dementia Aggression Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Social Behavior Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North York General Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

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 outcomes

  1. Neuropsychiatric Inventory Nursing Home Version

    Time frame: Screening, Baseline, 1 month, 2 months, 3 months

  2. Clinical Global Impression of Change

    Time frame: Baseline, 1 month, 2 months, 3 months

Secondary outcomes

  1. Neuropsychiatric Inventory Nursing Home Version

    Time frame: Screening, baseline, 1 month, 2 months, 3 months

  2. Neuropsychiatric Inventory Burden Subscale

    Time frame: Screening, baseline, 1 month, 2 months, 3 months

  3. Cohen Mansfield Agitation Inventory

    Time frame: Baseline, 1 month, 2 months, 3 months

  4. Modified Nursing Care Assessment Scale

    Time frame: Baseline, 3 months

  5. Activities of Daily Living

    Time frame: Baseline, 3 months

  6. Quality of Life in Late Stage Dementia

    Time frame: Baseline, 3 months

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Lundbeck Canada Inc.

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2006
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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