Donepezil in the Prevention of Post-Operative Cognitive Decline

Completed · Phase 4

Conditions studied: Postoperative Complications, Delirium

In brief

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.

Key facts

Study ID

NCT00182845

Run by

Pfizer

People needed

30

Starts

2005-02-01

Expected to finish

2007-04-01

Last updated by the study team

2008-03-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital, Clarian Health Partners — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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