Memantine for Agitation and Aggression in Severe Alzheimer's Disease

NCT00401167 | Completed Phase 4

• 1 other identifier: Lundbeck-11267
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; behavioral and psychological symptoms of dementia; severe Alzheimer's disease; memantine; agitation; aggression

Outcome Measures

Primary Outcomes (2)

• Neuropsychiatric Inventory Nursing Home Version

  Screening, Baseline, 1 month, 2 months, 3 months

• Clinical Global Impression of Change

  Baseline, 1 month, 2 months, 3 months

Secondary Outcomes (6)

• Neuropsychiatric Inventory Nursing Home Version

  Screening, baseline, 1 month, 2 months, 3 months

• Neuropsychiatric Inventory Burden Subscale

  Screening, baseline, 1 month, 2 months, 3 months

• Cohen Mansfield Agitation Inventory

  Baseline, 1 month, 2 months, 3 months

• Modified Nursing Care Assessment Scale

  Baseline, 3 months

• Activities of Daily Living

  Baseline, 3 months

Interventions

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Lundbeck Canada Inc.: collaborator

Study Sites (2)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 21476613 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Behavior; Psychomotor Agitation; Aggression

Interventions

Memantine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nathan Herrmann, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 31, 2024

Record last verified: 2010-01

Locations

CA (2)