A Phase 2 interventional study of Imaging with flutemetamol F 18 PET/CT in Cognitive Impairment, Carotid Artery Plaque and Inflammation, sponsored by Scott Mcnally. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Scott Mcnally · Phase 2, Interventional, and Diagnostic
The invesigators propose a clinical study on patients undergoing carotid surgery (endarterectomy). The invesigators will determine carotid artery imaging features associated with (1) vessel wall inflammation, (2) downstream brain inflammation, and (3) cognitive benefit from surgery. This project will uncover links between inflamed carotid plaque and downstream brain inflammation. The invesigators will also determine carotid plaque imaging features predicting cognitive benefit from carotid surgery.
This research is directed at a major stroke source, the carotid artery, a major vessel that supplies blood to the brain. It has long been known that carotid narrowing is an important stroke risk factor. However, many patients with narrow carotids do not have strokes, and many patients with seemingly normal carotids have strokes. MRI research now suggests that the carotid wall itself is the stroke source. Using carotid MRI, clinicians can identify previously invisible markers of unstable carotid plaque, including carotid wall bleeds (intraplaque hemorrhage). The working hypothesis is that patients with these unstable carotid plaques may have higher inflammation in both their carotid arteries and brain. This inflammation has been implicated in other diseases, including dementia.
Carotid wall bleeds can easily be seen with carotid MRI, but are often invisible on ultrasound and CT scans. By using MRI, the invesigators have found that this silent killer is an important stroke risk factor even without carotid narrowing. Now that imaging can detect carotid wall bleeds, where do the bleeds come from? Recent research points to inflammation within the carotid wall. The invesigators plan to use histology to detect this inflammation in the vessel wall. Another question is, does inflammation in the carotid wall lead to inflammation in the brain? Using PET scans, the invesigators plan to determine whether inflammation in the brain is linked to carotid disease. Lastly, the invesigators hope to find out if carotid wall inflammation contributes to memory loss and if surgery is beneficial in these patients.
The invesigators hope to detect this inflammation in the vessel wall and brain before patients develop stroke, memory loss and dementia. This will be of huge benefit not only in the detection of diseases, but would also allow clinicians to monitor treatment effect on both carotid disease and brain inflammation. The invesigators also hope to use these tools to detect early treatment response. This research will accelerate the pace of future clinical trials to bring important new medications to patients sooner.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 45 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →This is the only study on the registry with Scott Mcnally as lead sponsor.
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Exclusion Criteria:
This group includes all enrolled subjects (those with carotid disease and plans to undergo surgery).
Drug: Imaging with flutemetamol F 18 PET/CT
All subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT
Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry.
Carotid plaque inflammation will be calculated with quantitative immunohistochemistry and correlated with intraplaque hemorrhage while controlling for confounders.
Time frame: baseline
Carotid MRI-detected intraplaque hemorrhage and prediction of brain inflammation on PET/CT.
Outcome 2. The primary outcome, brain inflammation will be compared in carotid intraplaque hemorrhage positive and negative sides, controlling for confounders including stenosis and perfusion.
Time frame: baseline
Preoperative MRI-detected carotid intraplaque hemorrhage and prediction of cognitive improvement after endarterectomy.
Outcome 3. The primary outcome, difference in cognitive score will be compared in carotid intraplaque hemorrhage positive and negative patients, controlling for stenosis, perfusion and ischemic symptoms.
Time frame: Change from baseline at 3 month followup
Plan to share: Yes — All data will be made freely and publicly available on ClinicalTrials.gov within 12 months of the end of the funding period (and any no-cost extension). 1. Carotid intraplaque hemorrhage 2. Carotid plaque inflammation on histology 3. Age, stroke status, male sex, smoking and vitamin D level 4. Statin, antiplatelet, or antihypertensive use 5. Ipsilateral brain inflammation measured by PET 6. Carotid stenosis and perfusion parameters 7. Cognitive score
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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