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Trial record 1 of 1 for:    NCT00182845
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Donepezil in the Prevention of Post-Operative Cognitive Decline

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ClinicalTrials.gov Identifier: NCT00182845
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 3, 2008
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date March 3, 2008
Study Start Date  ICMJE February 2005
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2006)
Changes in the International Study of Post-Operative Cognitive Decline (ISPOCD) and the CogHealth computerized battery tests at 1 week and 12 weeks after surgery
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Changes in the International Study of Post-Operative Cognitive Decline (ISPOCD) and the CogHealth computerized battery tests at 1 week and 12 weeks after surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) daily during the post-operative period
  • Global cognitive status assessed using the Mini Mental Status Exam (MMSE)
  • Length of stay in the hospital post-operatively
  • Discharge site
  • Adverse effects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donepezil in the Prevention of Post-Operative Cognitive Decline
Official Title  ICMJE Preventing Post-Operative Cognitive Decline
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 impairment (MCI) and are undergoing elective hip or knee replacement.
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, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Complications
  • Delirium
Intervention  ICMJE Drug: Donepezil
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00182845
Other Study ID Numbers  ICMJE IA0078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Malaz Boustani, MD, MPH Regenstrief Institute, Indiana University Center for Aging Research
PRS Account National Institute on Aging (NIA)
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP