Donepezil in the Prevention of Post-Operative Cognitive Decline

NCT00182845 | Completed Phase 4

• 1 other identifier: IA0078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications; Delirium

Keywords

dementia; MCI; Aricept; Adverse Effects; Hospital Acquired Complications; Cognitive Impairment; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Donepezil DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

University Hospital, Clarian Health Partners

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• 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.

  PMID: 9861139 BACKGROUND

• Rasmussen LS. Defining postoperative cognitive dysfunction. Eur J Anaesthesiol. 1998 Nov;15(6):761-4. doi: 10.1097/00003643-199811000-00026. No abstract available.

  PMID: 9884870 BACKGROUND

• 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.

  PMID: 9525362 BACKGROUND

• 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.

  PMID: 11065205 BACKGROUND

• 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.

  PMID: 12170047 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Delirium; Dementia; Cognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Cognition Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Malaz Boustani, MD, MPH

  Regenstrief Institute, Indiana University Center for Aging Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 3, 2008

Record last verified: 2008-02

Locations

US (1)