Postoperative Cognitive DysfunctionPhase 4NCT01606488
Effects of Brain Beta-Amyloid on Postoperative Cognition
A Phase 4 study testing Florbetapir F 18 (18F-AV-45) in people with Postoperative Cognitive Dysfunction, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Florbetapir F 18 (18F-AV-45)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Florbetapir F 18 (18F-AV-45), no intervention
- Keywords
- Postoperative Cognitive Dysfunction, Postoperative Cognitive Decline, POCD, Alzheimer's disease, Florbetapir F 18 (18F-AV-45)
- Medical subject headings
- Postoperative Cognitive Complications, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florbetapir F 18 (18F-AV-45)Drug
Also called Florbetapir, Amyvid 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.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Surgical Group | Other | 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. Receives: Drug: Florbetapir F 18 (18F-AV-45) |
| Non-surgical group | Other | 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Decline
Measured using comprehensive neurocognitive test battery
Measured: At the time of discharge (or at the latest on the 7th postoperative day)
Secondary outcomes (14)
Genetic Polymorphisms
Measured by obtaining blood sample
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Vagus nerve tone assessment
Measured using Heart Rate Variability (HRV)
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Inflammatory Markers
Measured by obtaining blood samples
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Perioperative Complications
Measured using patient medical records
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Delirium
Measured using the Confusion Assessment Method rating scale (CAM) or the CAM-ICU if admitted to the intensive care unit
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Coma Assessment
Measured using the Richmond Agitation Sedation Scale (RASS)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Hospital Length of Stay
Measured using patient medical records
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Postoperative Complications
Measured using patient medical records
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Cognition
Measured using comprehensive neurocognitive test battery
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Quality of Life
Measured by assessing functional status using the Functional Activities Questionnaire and depression using the Geriatric Depression Scale
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Mortality
Measured using patient medical records
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Pain intensity
Measured using the Numerical Rating Scale
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Pain unpleasantness
Measured using the Numerical Rating Scale
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Post-traumatic Stress Disorder symptomatology
Measured using the PTSD Checklist
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Avid Radiopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Marek Brzezinski, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606488
- Sponsor's protocol ID
- 20110506
- Other IDs
- 18F-AV-45-A14
- Status last verified
- Apr 2025
- First submitted
- 23 May 2012
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brain Beta Amyloid on Postoperative Cognition and 18F-AV-45-A14: Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
- ClinicalTrials.gov ID
- NCT01606488
- Acronym / sponsor ID
- 20110506
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative Cognitive Dysfunction, Postoperative Cognitive Decline, POCD, Alzheimer's disease, Florbetapir F 18 (18F-AV-45)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Avid Radiopharmaceuticals
- Study start
- May 2012 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Group | Other | Drug: Florbetapir F 18 (18F-AV-45)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. |
| Non-surgical group | Other | Other: no interventionSubjects 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florbetapir F 18 (18F-AV-45)Also: Florbetapir, Amyvid 18F-AV-45Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan. | Drug | Surgical Group |
| no intervention | Other | Non-surgical group |
Primary outcome
Cognitive Decline
Time frame: At the time of discharge (or at the latest on the 7th postoperative day)
Measured using comprehensive neurocognitive test battery
14 secondary outcomes
Genetic Polymorphisms
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Vagus nerve tone assessment
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Inflammatory Markers
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Perioperative Complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Coma Assessment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Hospital Length of Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Postoperative Complications
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Cognition
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Quality of Life
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Mortality
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Pain intensity
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Pain unpleasantness
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Post-traumatic Stress Disorder symptomatology
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Cognitive Dysfunction
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Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Brzezinski, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Florbetapir F 18 (18F-AV-45) in people with Postoperative Cognitive Dysfunction, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Decline (time frame: At the time of discharge (or at the latest on the 7th postoperative day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.