Effects of Brain Beta-Amyloid on Postoperative Cognition

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Alzheimer's Drug Discovery Foundation; Alzheimer’s Drug Discovery Foundation; Avid Radiopharmaceuticals

Criteria

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