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 |
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.
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
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