Donepezil in the Prevention of Post-Operative Cognitive Decline

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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 impairment (MCI) and are undergoing elective hip or knee replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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