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66 Participants Needed

Brain Beta-Amyloid for Postoperative Cognitive Dysfunction

Overseen ByMarek Brzezinski, MD, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Cardiovascular disease, Severe psychiatric disorders, Dementia, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the effectiveness of the drug Florbetapir F 18 (18F-AV-45) for treating postoperative cognitive dysfunction?

Florbetapir F 18 is effective in imaging amyloid plaques in the brain, which are linked to cognitive issues in Alzheimer's disease. This imaging capability may help identify amyloid-related cognitive dysfunction after surgery, although direct evidence for treating postoperative cognitive dysfunction is not provided.¹ ² ³ ⁴ ⁵

Is Florbetapir F 18 safe for use in humans?

Florbetapir F 18 has been well-tolerated in studies involving more than 2000 human subjects, with no significant safety concerns reported. It is primarily excreted through the liver and has a whole body effective radiation dose of 7 mSv from a typical dose, which is considered safe for medical imaging purposes.¹ ² ³ ⁵ ⁶

How does the treatment for postoperative cognitive dysfunction involving brain beta-amyloid differ from other treatments?

This treatment is unique because it focuses on the role of beta-amyloid (a protein associated with Alzheimer's disease) in postoperative cognitive dysfunction, potentially using its levels as biomarkers to predict outcomes. Unlike other treatments, it may involve monitoring changes in beta-amyloid levels in the brain or blood to understand and manage cognitive decline after surgery.⁷ ⁸ ⁹ ¹⁰ ¹¹

What is the purpose of this trial?

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.

Research Team

Marek Brzezinski, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

I am not expected to need a breathing tube after surgery.

I can see and hear well enough for brain function tests.

Subjects with Clinical Dementia Rating Scale (CDR) of 0-0.5

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Exclusion Criteria

I haven't had any radiopharmaceuticals for imaging or therapy in the last 24 hours.

CDR score > 0.5

History of relevant severe drug allergy or hypersensitivity

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo florbetapir PET scan and baseline neurocognitive assessments

1 week

1 visit (in-person)

Surgery and Immediate Postoperative

Participants undergo surgery and are monitored for cognitive decline and other complications

1 week

Daily monitoring during hospital stay

Follow-up

Participants are monitored for cognitive decline, quality of life, and other outcomes

1 year

Regular follow-up visits

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Surgical GroupExperimental Treatment1 Intervention

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.

Group II: Non-surgical groupExperimental Treatment1 Intervention

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.