Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401167
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2006-11-16
Brief Title:
Memantine for Agitation and Aggression in Severe Alzheimers Disease
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Phase IV-An Open-Label Prospective Study of Memantine in Institutionalized Patients With Severe Alzheimers Disease and Significant Behavioural and Psychological Symptoms of Dementia
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alzheimers 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
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 Alzheimers disease patient population It is for this reason we propose an open-label prospective study of memantine in institutionalized patients with severe Alzheimers 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 Alzheimers disease will be assessed in a 3-month open-label study involved 32 patients residing in long-term care facilities
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 Alzheimers disease will be assessed in a 3-month open-label study involved 32 patients residing in long-term care facilities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None