Effects of Brain Beta-Amyloid on Postoperative Cognition



Status:Recruiting
Conditions:Cognitive Studies, Hospital
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:65 - Any
Updated:5/19/2018
Start Date:May 2012
End Date:June 2019
Contact:Marek Brzezinski, MD, PhD
Email:brzezinm@anesthesia.ucsf.edu
Phone:877-487-2838

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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)

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
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
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Marek Brzezinski, MD, PhD
?
mi
from
San Francisco, CA
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