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Postoperative ComplicationsPhase 4NCT00182845

Donepezil in the Prevention of Post-Operative Cognitive Decline

A Phase 4 study testing Donepezil in people with Postoperative Complications and Delirium, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Postoperative Complications, Delirium
What is being tested?
Donepezil
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2005to Apr 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospital, Clarian Health Partners

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Preventing Post-Operative Cognitive Decline

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.

Read the 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.

Being tested
Donepezil
Keywords
dementia, MCI, Aricept, Adverse Effects, Hospital Acquired Complications, Cognitive Impairment, Aging
Medical subject headings
Postoperative Complications, Delirium, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonepezilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) daily during the post-operative period

  2. Global cognitive status assessed using the Mini Mental Status Exam (MMSE)

  3. Length of stay in the hospital post-operatively

  4. Discharge site

  5. Adverse effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00182845
Sponsor's protocol ID
IA0078
Status last verified
Feb 2008
First submitted
9 Sep 2005
Last updated
3 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 9861139

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

    PubMed 9884870

  • 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.

    PubMed 9525362

  • 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.

    PubMed 11065205

  • 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.

    PubMed 12170047

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Donepezil in people with Postoperative Complications and Delirium, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00182845, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2008.

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