Status:
COMPLETED
Memantine for Agitation and Aggression in Severe Alzheimer's Disease
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Lundbeck Canada Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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, ther...
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00401167
Start Date
November 1 2006
End Date
January 1 2010
Last Update
January 31 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5