Status:
COMPLETED
Donepezil in the Prevention of Post-Operative Cognitive Decline
Lead Sponsor:
Pfizer
Conditions:
Postoperative Complications
Delirium
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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 im...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- Community-dwelling individuals aged 65 or older
- Scheduled for elective hip or knee replacement at University Hospital
- Mild cognitive impairment, defined as:
- MMSE total score of 27 or less;
- normal performance of the activities of daily living tasks of the Bristol scale after excluding mobility related difficulties;
- no chart-based dementia diagnosis; and
- no history of ever being on dementia medications such as Memantine or any cholinesterase inhibitors
- Consent to participate in the study
Exclusion
- Chart-based dementia diagnosis
- MMSE score greater than 27
- Difficulty performing the activities of daily living not related to mobility as measured by the Bristol scale
- Current or past history of receiving dementia medications such as Memantine or any cholinesterase inhibitors (Tacrine, Donepezil, Rivastigmine, or Galantamine)
- Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months
- Multiple trauma or pathological fractures requiring acute hip or knee replacement
- Aphasic, blind, or deaf
- Use of neuroleptics one month prior to surgery
- Allergy to donepezil
- Inability to read and complete study tests and forms
- Alcohol or drug dependence, defined as intake of more than 5 units of alcohol daily during the past 3 months
- Not expected to be discharged from hospital or able to complete the 3-month postoperative test
- Not competent to make medical decisions
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00182845
Start Date
February 1 2005
End Date
April 1 2007
Last Update
March 3 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital, Clarian Health Partners
Indianapolis, Indiana, United States, 46202