Discontinuation of Cholinesterase Inhibitors for the Treatment of Severe Alzheimer's Disease
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
There are few pharmacological treatments available for Alzheimer's disease, including drugs
called cholinesterase inhibitors: donepezil, galantamine, and rivastigmine. In research
trials, cholinesterase inhibitors have been shown to improve memory and problem behaviours in
people with mild to moderate Alzheimer's disease. However, these benefits may not extend to
the real-world when taking into account nursing home and health care costs. There is less
information on the use of cholinesterase inhibitors in people with severe Alzheimer's
disease. In Canada, only donepezil is recommended for the treatment of severe Alzheimer's
disease. However, there is no information on whether the benefits that donepezil provides to
people with severe Alzheimer's disease are sustained over the long term. Moreover, while the
tolerability of cholinesterase inhibitors is generally acceptable, their use is not
completely harmless. Common side effects include nausea, diarrhea, insomnia, vomiting, muscle
cramping, fatigue and loss of appetite.
In Ontario, cholinesterase inhibitor users tend to remain on these medications for two years
or more and often until death. The current cholinesterase inhibitor guidelines provide
details on what medication should be used, when it should be started and how it should be
monitored, but there is less clarity on when it is safe and appropriate to stop treatment.
The cessation of cholinesterase inhibitors in patients no longer appearing to display any
clear benefits may help to lower the risk of unpleasant side effects, lower the use of
multiple medications, and reduce the costs of caring for individuals with Alzheimer's
disease. However, the cessation of cholinesterase inhibitor therapy may run the risk of
deterioration in memory, worsening or development of behavioural symptoms and the placement
of additional demands on professional and unpaid caregivers.
There is a clear need for guidelines when to stop cholinesterase inhibitor treatment,
especially for patients in whom the benefits of not be on the medication will outweigh the
risks. The purpose of this study is to address this issue by collecting data which may be
helpful in predicting which types of patients may benefit from stopping cholinesterase
inhibitor treatment. Understanding when, and for whom, it is appropriate to stop
cholinesterase inhibitor treatment will influence the field of pharmacology in the treatment
of Alzheimer's disease.