Back to resultsDonepezil in the Prevention of Post-Operative Cognitive Decline
Primary Purpose
Postoperative Complications, Delirium
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Donepezil
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring dementia, MCI, Aricept, Adverse Effects, Hospital Acquired Complications, Cognitive Impairment, Aging
Eligibility 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
Sites / Locations
- University Hospital, Clarian Health Partners
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00182845
Brief Title
Donepezil in the Prevention of Post-Operative Cognitive Decline
Official Title
Preventing Post-Operative Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Delirium
Keywords
dementia, MCI, Aricept, Adverse Effects, Hospital Acquired Complications, Cognitive Impairment, Aging
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Donepezil
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) daily during the post-operative period
Title
Global cognitive status assessed using the Mini Mental Status Exam (MMSE)
Title
Length of stay in the hospital post-operatively
Title
Discharge site
Title
Adverse effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malaz Boustani, MD, MPH
Organizational Affiliation
Regenstrief Institute, Indiana University Center for Aging Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Clarian Health Partners
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9861139
Citation
Dodds C, Allison J. Postoperative cognitive deficit in the elderly surgical patient. Br J Anaesth. 1998 Sep;81(3):449-62. doi: 10.1093/bja/81.3.449. No abstract available.
Results Reference
background
PubMed Identifier
9884870
Citation
Rasmussen LS. Defining postoperative cognitive dysfunction. Eur J Anaesthesiol. 1998 Nov;15(6):761-4. doi: 10.1097/00003643-199811000-00026. No abstract available.
Results Reference
background
PubMed Identifier
9525362
Citation
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0. Erratum In: Lancet 1998 Jun 6;351(9117):1742.
Results Reference
background
PubMed Identifier
11065205
Citation
Abildstrom H, Rasmussen LS, Rentowl P, Hanning CD, Rasmussen H, Kristensen PA, Moller JT. Cognitive dysfunction 1-2 years after non-cardiac surgery in the elderly. ISPOCD group. International Study of Post-Operative Cognitive Dysfunction. Acta Anaesthesiol Scand. 2000 Nov;44(10):1246-51. doi: 10.1034/j.1399-6576.2000.441010.x.
Results Reference
background
PubMed Identifier
12170047
Citation
Johnson T, Monk T, Rasmussen LS, Abildstrom H, Houx P, Korttila K, Kuipers HM, Hanning CD, Siersma VD, Kristensen D, Canet J, Ibanaz MT, Moller JT; ISPOCD2 Investigators. Postoperative cognitive dysfunction in middle-aged patients. Anesthesiology. 2002 Jun;96(6):1351-7. doi: 10.1097/00000542-200206000-00014.
Results Reference
background
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Donepezil in the Prevention of Post-Operative Cognitive Decline
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