Effects of Brain Beta-Amyloid on Postoperative Cognition

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01606488
• Other study ID #: 20110506
• Secondary ID: 18F-AV-45-A14
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: University of California, San Francisco
• Contact: Marek Brzezinski, MD, PhD
• Phone: 877-487-2838
• Email: brzezinm[@]anesthesia.ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Florbetapir 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.

Other:
• no intervention

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Alzheimer's Drug Discovery Foundation, Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Decline	Measured using comprehensive neurocognitive test battery	At the time of discharge (or at the latest on the 7th postoperative day)
Secondary	Genetic Polymorphisms	Measured by obtaining blood sample	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Vagus nerve tone assessment	Measured using Heart Rate Variability (HRV)	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Inflammatory Markers	Measured by obtaining blood samples	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Perioperative Complications	Measured using patient medical records	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Delirium	Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Coma Assessment	Measured using the Richmond Agitation Sedation Scale (RASS)	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Hospital Length of Stay	Measured using patient medical records	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Postoperative Complications	Measured using patient medical records	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Change in Cognition	Measured using comprehensive neurocognitive test battery	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Quality of Life	Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Mortality	Measured using patient medical records	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Pain intensity	Measured using the Numerical Rating Scale	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Pain unpleasantness	Measured using the Numerical Rating Scale	Participants will be followed from preoperative baseline to 1 year postoperative
Secondary	Post-traumatic Stress Disorder symptomatology	Measured using the PTSD Checklist	Participants will be followed from preoperative baseline to 1 year postoperative