Donepezil in the Prevention of Post-Operative Cognitive Decline

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00182845
First received: September 9, 2005
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Postoperative Complications
Delirium
Drug: Donepezil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Preventing Post-Operative Cognitive Decline

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: February 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182845

Locations
United States, Indiana
University Hospital, Clarian Health Partners
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Pfizer
Investigators
Principal Investigator: Malaz Boustani, MD, MPH Regenstrief Institute, Indiana University Center for Aging Research
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00182845     History of Changes
Other Study ID Numbers: IA0078
Study First Received: September 9, 2005
Last Updated: February 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
dementia
MCI
Aricept
Adverse Effects
Hospital Acquired Complications
Cognitive Impairment
Aging

Additional relevant MeSH terms:
Delirium
Postoperative Complications
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014