Effects of Brain Beta-Amyloid on Postoperative Cognition

University of California San Francisco (UCSF)

Status and phase: Active, not recruiting; Phase 4

Conditions: Postoperative Cognitive Dysfunction

Treatments: Other: no intervention; Drug: Florbetapir F 18 (18F-AV-45)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01606488

18F-AV-45-A14

20110506

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Surgical Group

Other group

Description:

Subjects scheduled to undergo total knee or total hip replacement at the SFVAMC. Subjects in this arm of the study will undergo the florbetapir PET scan once prior to their surgery. Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers.

Treatment:

Drug: Florbetapir F 18 (18F-AV-45)

Non-surgical group

Other group

Description:

Subjects being seen in at the SFVAMC orthopedic clinic for knee or hip pain but are not anticipating surgical intervention. Subjects in this arm will not undergo the florbetapir PET scan. Subjects in this arm of the study will undergo serial neurocognitive assessment, heart rate variability measurement, and blood draws for genetic and inflammatory markers.

Treatment:

Other: no intervention