Effects of Brain Beta-Amyloid on Postoperative Cognition

a study on Postoperative Cognitive Dysfunction

Summary

for people ages 65 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Marek Brzezinski

Description

Summary

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.

Official Title

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

Keywords

Postoperative Cognitive Dysfunction Postoperative Cognitive Decline POCD Alzheimer's disease Florbetapir F 18 (18F-AV-45) Cognitive Dysfunction no intervention

Eligibility

You can join if…

Open to people ages 65 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientist

  • Marek Brzezinski
    Professor, Anesthesia. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01606488
Phase
Phase 4
Study Type
Interventional
Last Updated