Delirium Clinical Trial
Official title:
Preventing Post-Operative Cognitive Decline
Verified date | February 2008 |
Source | National Institute on Aging (NIA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University Hospital, Clarian Health Partners | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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. — View Citation
Dodds C, Allison J. Postoperative cognitive deficit in the elderly surgical patient. Br J Anaesth. 1998 Sep;81(3):449-62. Review. — View Citation
Johnson T, Monk T, Rasmussen LS, Abildstrom H, Houx P, Korttila K, Kuipers HM, Hanning CD, Siersma VD, Kristensen D, Canet J, Ibañaz MT, Moller JT; ISPOCD2 Investigators. Postoperative cognitive dysfunction in middle-aged patients. Anesthesiology. 2002 Jun;96(6):1351-7. — View 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. Erratum in: Lancet 1998 Jun 6;351(9117):1742. — View Citation
Rasmussen LS. Defining postoperative cognitive dysfunction. Eur J Anaesthesiol. 1998 Nov;15(6):761-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) daily during the post-operative period | |||
Secondary | Global cognitive status assessed using the Mini Mental Status Exam (MMSE) | |||
Secondary | Length of stay in the hospital post-operatively | |||
Secondary | Discharge site | |||
Secondary | Adverse effects |
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