Delirium Clinical Trial
Official title:
Preventing Post-Operative Cognitive Decline
The purpose of this study is to evaluate the feasibility of using Donepezil to prevent post-operative cognitive decline (POCD) among individuals aged 65 and older who have a baseline mild cognitive impairment (MCI) and are undergoing elective hip or knee replacement.
Up to 65% of elderly patients undergoing hip or knee surgery suffer from declining brain
function known as post-operative cognitive decline (POCD). These individuals often stay in
the hospital longer, have more complications, and are more likely to die. Recent clinical
studies have shown the potential benefit of enhancing the cholinergic system among patients
with both Alzheimer's disease and / or vascular dementia. Donepezil is currently being used
to treat memory loss in patients with Alzheimer's disease.
This study will recruit 30 cognitively impaired adults aged 65 or older who are scheduled to
have elective hip or knee replacement surgery at University Hospital. Participants will be
randomized to receive either a three to six week supply of Donepezil or a matching placebo
approximately 4 weeks prior to surgery. This study will evaluate the effect of Donepezil on
delirium incidence and severity during hospitalization, global cognitive function, length of
hospitalization, site of discharge, and adverse drug effects.
All material to be collected will be from interviews, questionnaires, and medical chart
review. Some will be at baseline, during hospitalization, and 12 weeks post hospitalization
and others will be daily during hospitalization. The International Study of Post-Operative
Cognitive Decline battery of tests will be used in assessment, as will the CogHealth
computerized battery.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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