Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cognitive Decline
研究概览
简要总结
Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients greater than or equal to 65 years of age.
This study will test the hypothesis that preoperative presence of brain beta-amyloid plaques in non-demented subjects increases postoperative cognitive decline (POCD) in elderly subjects scheduled for hip or knee replacement.
The investigators hypothesize that preoperative beta-amyloid plaques will predict postoperative cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for total knee arthroplasty or total hip arthroplasty under general anesthesia (primary arthroplasties and revisions)
- •English speaking
- •Anticipated stay in the hospital
- •Not anticipated to stay intubated postoperatively
- •Patients who live with or have regular visits from an individual ("study partner") willing to provide information about the patient's cognitive status
- •Willing and able to undergo all testing procedures including neuroimaging and agree to longitudinal follow up
- •Adequate visual and auditory acuity to allow neuropsychological testing
- •Subjects with Clinical Dementia Rating Scale (CDR) of 0-0.5
- •Patients who are not demented
- •Subjects sho signed an IRB approved informed consent prior to any study procedures
排除标准
- •Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject
- •Current clinically significant cardiovascular disease.
- •History of drug or alcohol abuse within the last year, or prior prolonged history of abuse
- •Clinically significant infections disease, including Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive test for hepatitis
- •History of relevant severe drug allergy or hypersensitivity
- •Received an investigational medication under an FDA IND protocol within the last 30 days.
- •Current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject
- •Received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
- •Severe psychiatric disorders including schizophrenia, bipolar disorders, and major depression as described in DSM-IV within the past year (medical record, GDS score, interview with the patient and study partner)
- •Obvious causes for their cognitive impairment (e.g. onset coincides with recent head trauma or stroke)
- •Dementia of any cause
- •CDR score > 0.5
- •Expressed the preference to undergo the procedure under regional anesthesia in form of spinal or epidural anesthesia
- •Patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type
研究组 & 干预措施
Surgical Group
Subjects scheduled to undergo total knee or total hip replacement at the SFVAMC.
Subjects in this arm of the study will undergo the florbetapir PET scan once prior to their surgery.
Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers.
干预措施: Florbetapir F 18 (18F-AV-45) (Drug)
Non-surgical group
Subjects being seen in at the SFVAMC orthopedic clinic for knee or hip pain but are not anticipating surgical intervention.
Subjects in this arm will not undergo the florbetapir PET scan.
Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers.
干预措施: no intervention (Other)
结局指标
主要结局
Cognitive Decline
时间窗: At the time of discharge (or at the latest on the 7th postoperative day)
Measured using comprehensive neurocognitive test battery
次要结局
- Vagus nerve tone assessment(Participants will be followed from preoperative baseline to 1 year postoperative)
- Postoperative Complications(Participants will be followed from preoperative baseline to 1 year postoperative)
- Change in Cognition(Participants will be followed from preoperative baseline to 1 year postoperative)
- Pain unpleasantness(Participants will be followed from preoperative baseline to 1 year postoperative)
- Coma Assessment(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Genetic Polymorphisms(Participants will be followed from preoperative baseline to 1 year postoperative)
- Inflammatory Markers(Participants will be followed from preoperative baseline to 1 year postoperative)
- Perioperative Complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Delirium(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Post-traumatic Stress Disorder symptomatology(Participants will be followed from preoperative baseline to 1 year postoperative)
- Hospital Length of Stay(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Quality of Life(Participants will be followed from preoperative baseline to 1 year postoperative)
- Mortality(Participants will be followed from preoperative baseline to 1 year postoperative)
- Pain intensity(Participants will be followed from preoperative baseline to 1 year postoperative)