- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00182845
Donepezil in the Prevention of Post-Operative Cognitive Decline
Preventing Post-Operative Cognitive Decline
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 4단계
연락처 및 위치
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202
- University Hospital, Clarian Health Partners
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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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
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2차 결과 측정
결과 측정 |
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부작용
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Delirium status measured by the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) daily during the post-operative period
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Global cognitive status assessed using the Mini Mental Status Exam (MMSE)
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Length of stay in the hospital post-operatively
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Discharge site
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Malaz Boustani, MD, MPH, Regenstrief Institute, Indiana University Center for Aging Research
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- Rasmussen LS. Defining postoperative cognitive dysfunction. Eur J Anaesthesiol. 1998 Nov;15(6):761-4. doi: 10.1097/00003643-199811000-00026. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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