NCT01606488 · Phase 4 · ACTIVE NOT RECRUITING
Effects of Brain Beta-Amyloid on Postoperative Cognition
This study uses a brain scan with a tracer called florbetapir to check for amyloid plaques before hip or knee replacement surgery. Researchers then track whether people with plaques show more memory and thinking decline afterward. Phase 4 means the tracer is already approved for imaging. Here it is used to study surgery outcomes, not to treat anything.
You may qualify if
- 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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-01