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OpenTrials
Active, Not Recruiting

NCT Number: NCT01606488

Effects of Brain Beta-Amyloid on Postoperative Cognition

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Florbetapir F 18 (18F-AV-45)

Drug

Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan.

Other names: Florbetapir, Amyvid 18F-AV-45

No intervention

Other

Primary outcomes

  1. Cognitive Decline

    Time frame: At the time of discharge (or at the latest on the 7th postoperative day)

    Measured using comprehensive neurocognitive test battery

Secondary outcomes

  1. Genetic Polymorphisms

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured by obtaining blood sample

  2. Vagus nerve tone assessment

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using Heart Rate Variability (HRV)

  3. Inflammatory Markers

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured by obtaining blood samples

  4. Perioperative Complications

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

    Measured using patient medical records

  5. Delirium

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

    Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit

  6. Coma Assessment

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

    Measured using the Richmond Agitation Sedation Scale (RASS)

  7. Hospital Length of Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

    Measured using patient medical records

  8. Postoperative Complications

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using patient medical records

  9. Change in Cognition

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using comprehensive neurocognitive test battery

  10. Quality of Life

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale

  11. Mortality

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using patient medical records

  12. Pain intensity

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using the Numerical Rating Scale

  13. Pain unpleasantness

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using the Numerical Rating Scale

  14. Post-traumatic Stress Disorder symptomatology

    Time frame: Participants will be followed from preoperative baseline to 1 year postoperative

    Measured using the PTSD Checklist

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Alzheimer's Drug Discovery Foundation
  • Avid Radiopharmaceuticals

Registry information

Official study title

Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
May 25, 2012
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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