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临床试验/NCT03676738
NCT03676738已完成不适用

Cohort Study of Risk Factors for Postoperative Cognitive Decline

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Genetic Variables

研究概览

简要总结

Presently, the role of either genetic factors or biological sex in the development of postoperative cognitive dysfunction (POCD) is unknown. There is a critical need to determine which individuals are at high-risk for developing POCD by virtue of biological sex or genetic predisposition. The knowledge gained in the described research has the potential to shed light on mechanistic pathways, a necessary next step in order to ultimately identify therapeutic strategies.

详细描述

Adults 65 years and older represent the fastest-growing age group in the United States, and account for one third of all surgical patients. These older adults are at the highest risk for deleterious postoperative neurocognitive outcomes. Postoperative cognitive dysfunction (POCD) occurs in up to 40% of older adults after major non-cardiac surgery. POCD is a syndrome characterized by a decrease in performance on neuropsychological test battery from before to after surgery. Neuropsychological testing for POCD typically spans cognitive domains including memory, attention, concentration, and/or executive function. There is an increasing body of literature suggesting that exposure to surgery and anesthesia increases the risk of Alzheimer's disease (AD). Surgery and anesthesia enhance neuropathologic changes known to underlie AD including amyloid beta accumulation and aggregation, neuroinflammation, increased levels of tau and tau phosphorylation, and memory decline. However, not everyone with a history of surgery and anesthesia develops POCD, suggesting biological risk factors are involved.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 89 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia
  • Presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder
  • Subjects must have sufficient vision and hearing to complete neuropsychological testing
  • Proficient in spoken and written English language

排除标准

  • Diagnosed dementia or dementia-related treatment (i.e. donepezil prescription, or memory-care facility residence)
  • Significant disease of the central nervous system (CNS) (i.e. Parkinson's disease)
  • History of stroke or traumatic brain injury
  • Major psychiatric disorder (i.e. schizophrenia)
  • Alcohol or drug abuse according to DSM-V within the last 2 years
  • Need for urgent/emergent surgery
  • Surgery/anesthesia within prior 12 months
  • Refusal of consent

结局指标

主要结局

Genetic Variables

时间窗: Six months

To determine whether specific genetic variables (i.e. APOE4 or PLA2 alleles) and/or biological sex confer a higher risk to developing postoperative cognitive and functional status decline in older adults.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katie J. Schenning

Principal Investigator

Oregon Health and Science University

研究点 (1)

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