CompletedPhase 4

Memantine for Agitation and Aggression in Severe Alzheimer's Disease

Canada31 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neuropsychiatric Inventory Nursing Home Version

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

Clinical Global Impression of Change

Timeframe: Baseline, 1 month, 2 months, 3 months

Trial details

NCT IDNCT00401167

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01