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


Brief 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.


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

– 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

– 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


  • San Francisco VA Medical Center, San Francisco, California, United States, 94121
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