Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Sponsor:
Brief Summary:
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.
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
Locations
- San Francisco VA Medical Center, San Francisco, California, United States, 94121