Brain Beta-Amyloid for Postoperative Cognitive Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether beta-amyloid plaques (protein deposits often linked to Alzheimer's) in the brain before surgery can predict cognitive decline after hip or knee replacement in older adults. It includes two groups: one undergoing surgery, receiving a special brain scan with Florbetapir F 18 (a diagnostic imaging agent) and various assessments, and another with similar joint pain but not undergoing surgery, who will also receive assessments. Ideal participants are those planning hip or knee replacement surgery, able to speak English, and living with someone who can report on their cognitive status. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for Florbetapir F 18 (18F-AV-45)?
Research has shown that florbetapir F 18, the treatment being tested in this study, has undergone thorough safety checks. It has been studied in many people and already holds FDA approval for other uses, indicating general safety when used correctly.
However, due to the small amount of radiation involved, specific safety steps must be followed to minimize radiation exposure. These precautions are standard for this type of imaging agent. Overall, evidence indicates that florbetapir F 18 is safe for use in clinical settings.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Florbetapir F 18 (18F-AV-45) because it offers a new way to address postoperative cognitive dysfunction (POCD), which is a common issue after surgeries like knee or hip replacements. Unlike standard treatments, which often focus on managing symptoms with cognitive and physical therapy, Florbetapir F 18 uses a PET scan to visualize brain beta-amyloid plaques, potentially identifying those at risk for POCD before surgery. This approach could lead to more personalized interventions, aiming to prevent cognitive issues rather than simply treating them after they occur. The ability to identify at-risk patients through imaging is what makes this approach particularly unique and promising.
What evidence suggests that this trial's treatment could be effective for postoperative cognitive decline?
Research shows that Florbetapir F 18 has been used safely in over 2,000 people. This imaging agent helps identify beta-amyloid plaques in the brain. In this trial, participants in the Surgical Group will undergo the florbetapir PET scan to assess these plaques before surgery. Some studies suggest that a higher presence of these plaques might increase the risk of memory and thinking problems post-surgery. However, other studies found that these plaques don't always predict who will experience these issues. While the predictive ability of this imaging for cognitive decline is still under investigation, it remains a valuable tool for understanding brain changes related to aging and surgery.36789
Who Is on the Research Team?
Marek Brzezinski, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for English-speaking adults aged 65 or older with mild cognitive issues, scheduled for knee or hip replacement surgery under general anesthesia. They must have someone to report on their cognition, be able to undergo tests including brain scans, and not expect post-surgery intubation. Excluded are those with significant heart disease, unstable conditions, recent radiopharmaceutical use, substance abuse history, severe allergies or infections like HIV/AIDS or hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants undergo florbetapir PET scan and baseline neurocognitive assessments
Surgery and Immediate Postoperative
Participants undergo surgery and are monitored for cognitive decline and other complications
Follow-up
Participants are monitored for cognitive decline, quality of life, and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Florbetapir F 18 (18F-AV-45)
Trial Overview
The study examines if the presence of beta-amyloid plaques in the brain before surgery can predict worsening of mental functions after surgery in elderly patients undergoing hip or knee replacements. It involves no direct intervention but uses a tracer called Florbetapir F 18 during brain imaging to detect these plaques.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Alzheimer's Drug Discovery Foundation
Collaborator
Avid Radiopharmaceuticals
Industry Sponsor
Dr. Daniel M. Skovronsky
Avid Radiopharmaceuticals
Chief Executive Officer since 2004
MD and PhD in Neuroscience from the University of Pennsylvania
Dr. Adam S. Fleisher
Avid Radiopharmaceuticals
Chief Medical Officer since 2022
MD, MAS
Citations
18F-florbetapir PET-determined Cerebral β-Amyloid ...
We hypothesized that 6-week 18F-florbetapir cortical amyloid burden would be greater in those patients manifesting postoperative cognitive dysfunction at 6 ...
Effects of Brain Beta-Amyloid on Postoperative Cognition
Summary. Postoperative cognitive decline (POCD) affects up to 50% of non-cardiac surgical patients greater than or equal to 65 years of age.
Brain Beta-Amyloid for Postoperative Cognitive Dysfunction
Florbetapir F 18 has been well-tolerated in studies involving more than 2000 human subjects, with no significant safety concerns reported.
(PDF) 18F-florbetapir Positron Emission Tomography ...
Results: The authors found that 6-week abnormal global cortical amyloid deposition was not associated with cognitive dysfunction (13 of 37, 35%) ...
18F-florbetapir Positron Emission Tomography-determined ...
Results: The authors found that 6-week abnormal global cortical amyloid deposition was not associated with cognitive dysfunction (13 of 37, 35%) at 6 weeks ...
AMYVID (florbetapir F 18 injection), for intravenous use
Handle AMYVID with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2)]. Use waterproof gloves ...
Cortical β-amyloid levels and neurocognitive performance ...
We chose 18F-florbetapir because: (1) it is the only tracer that has completed phase 2 and phase 3 studies; (2) it has safety data from a large ...
Florbetapir-PET β-amyloid imaging and associated ...
Data suggest that a significant percentage of patients will experience marked cognitive impairment after critical illness [3], [4], [5], [6], [7], yet questions ...
Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
This protocol is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in ...
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