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Effects of Brain Beta-Amyloid on Postoperative Cognition

Recruiting

This study will test the hypothesis that the presence of beta-amyloid plaques in the braina hallmark of Alzheimer's diseasein non-demented older patients increases the likelihood of cognitive decline after scheduled hip or knee replacement surgery.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years N/A All No
May 2012
June 2020
100

  • Scheduled for total knee or hip replacement with anticipated hospital stay
  • English speaking
  • Regular visits from an individual willing to provide information about the patient's cognitive status
  • Adequate seeing and hearing ability to allow neuropsychological testing
  • Clinical Dementia Rating Scale (CDR) score of 0-0.5 (no dementia)

  • Dementia of any cause; CDR score of > 0.5; obvious cause of cognitive impairment such as recent head trauma or stroke
  • Preference to undergo hip or knee replacement surgery under regional anesthesia in the form of spinal or epidural anesthesia
  • Expectation of staying intubated postoperatively
  • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances, which might pose a potential safety risk to the participant
  • Current clinically significant cardiovascular disease or other medical disease that might pose a safety risk to the participant
  • History of drug or alcohol abuse within the last year or prior prolonged history of abuse
  • Severe psychiatric disorders, including schizophrenia, bipolar disorders, or major depression
  • Clinically significant infectious 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 investigational new drug study within the last 30 days; received a radiopharmaceutical for imaging or therapy within 24 hours before this study's imaging session

Cognitive decline after surgery affects up to half of all noncardiac surgical patients who are 65 years old or older. This study will test the hypothesis that the presence of beta-amyloid plaques in the brain--a hallmark of Alzheimer's disease--in non-demented older patients increases the likelihood of cognitive decline after scheduled hip or knee replacement surgery. All participants will undergo neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers. The treatment group will also undergo a PET brain imaging scan with florbetapir F18 (18F-AV-45), an imaging agent; the control group will not.

Name City State Zip Status Primary Contact
San Francisco VA Medical Center
San Francisco California 94121 Recruiting

University of California, San Francisco

  • Alzheimer’s Drug Discovery Foundation
  • Avid Radiopharmaceuticals

Name Role Affiliation
Marek Brzezinski, MD, PhD Principal Investigator University of California, San Francisco

Name Phone Email
Ricarda Sawatzki 415-221-4810 ricarda.sawatzki@va.gov

NCT01606488

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