Postoperative Cognitive Dysfunction
Conditions
Keywords
Postoperative Cognitive Dysfunction, Postoperative Cognitive Decline, POCD, Alzheimer's disease, Florbetapir F 18 (18F-AV-45)
Brief 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.
Interventions
DRUGFlorbetapir F 18 (18F-AV-45)
Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan.
OTHERno intervention
Sponsors
Alzheimer's Drug Discovery Foundation
Avid Radiopharmaceuticals
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Decline | At the time of discharge (or at the latest on the 7th postoperative day) | Measured using comprehensive neurocognitive test battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genetic Polymorphisms | Participants will be followed from preoperative baseline to 1 year postoperative | Measured by obtaining blood sample |
| Vagus nerve tone assessment | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using Heart Rate Variability (HRV) |
| Inflammatory Markers | Participants will be followed from preoperative baseline to 1 year postoperative | Measured by obtaining blood samples |
| Perioperative Complications | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Measured using patient medical records |
| Delirium | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit |
| Coma Assessment | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Measured using the Richmond Agitation Sedation Scale (RASS) |
| Change in Cognition | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using comprehensive neurocognitive test battery |
| Postoperative Complications | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using patient medical records |
| Quality of Life | Participants will be followed from preoperative baseline to 1 year postoperative | Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale |
| Mortality | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using patient medical records |
| Pain intensity | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using the Numerical Rating Scale |
| Pain unpleasantness | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using the Numerical Rating Scale |
| Post-traumatic Stress Disorder symptomatology | Participants will be followed from preoperative baseline to 1 year postoperative | Measured using the PTSD Checklist |
| Hospital Length of Stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Measured using patient medical records |
Countries
United States
Outcome results
None listed