Cognitive ImpairmentPhase 2NCT03068442
The Role of Large Artery Plaque Imaging Features in Predicting Inflammation and Cognition
A Phase 2 study testing Imaging with flutemetamol F 18 PET/CT in people with Cognitive Impairment and Carotid Artery Plaque, run by Scott Mcnally at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Carotid Artery Plaque, Inflammation
- What is being tested?
- Imaging with flutemetamol F 18 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2017to 10 Sep 2030
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old and plans for carotid endarterectomy.
Who cannot join
- Patients with carotid occlusion will be excluded, due to one carotid contributing to both right and left brain blood supply.
- Other known sources of cardioembolism, including atrial fibrillation, mechanical heart valve, left atrial or ventricular thrombus or intracardiac mass, endocarditis, EF <30%
- Known stroke mimics including multiple sclerosis or brain tumor
- MRI contraindications per ACR guidelines, including patients with pacemakers, renal failure with eGFR<30 ml/min/1.73m2, and contrast allergy
- [18F]Flutemetamol contraindications per manufacturer guidelines, including patients with prior reactions
- Known stage IV malignancy
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84132
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148
About this study
Official title: Amyloid Deposition and Preexisting Vulnerable Carotid Plaque Features Predicting Cognitive Improvement After Surgery
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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Carotid Artery Plaque, Inflammation
- Being tested
- Imaging with flutemetamol F 18 PET/CT
- Keywords
- Carotid artery, MRI, PET, Intraplaque hemorrhage
- Medical subject headings
- Cognitive Dysfunction, Carotid Stenosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging with flutemetamol F 18 PET/CTDrug
All subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Carotid atherosclerosis group | Experimental | This group includes all enrolled subjects (those with carotid disease and plans to undergo surgery). Receives: Drug: Imaging with flutemetamol F 18 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 3 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start17 Feb 2017
- Primary completion10 Sep 2030 (estimated)
- Study completion10 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a diagnostic-interventional cohort study in patients undergoing carotid endarterectomy for atherosclerotic disease.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott Mcnally
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Scott Mcnally, University of Utah
- Investigators
- Joseph S McNally, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068442
- Sponsor's protocol ID
- 74088
- Status last verified
- May 2026
- First submitted
- 22 Feb 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid Deposition and Preexisting Vulnerable Carotid Plaque Features Predicting Cognitive Improvement After Surgery
- ClinicalTrials.gov ID
- NCT03068442
- Acronym / sponsor ID
- 74088
- Conditions
- Cognitive Impairment, Carotid Artery Plaque, Inflammation
- Keywords
- Carotid artery, MRI, PET, Intraplaque hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Scott McnallyUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 10 Sep 2030 (estimated)
- Study completion
- 10 Sep 2030 (estimated)
- First posted
- 1 Mar 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a diagnostic-interventional cohort study in patients undergoing carotid endarterectomy for atherosclerotic disease.
| Arm | Type | Receives |
|---|---|---|
| Carotid atherosclerosis group | Experimental | Drug: Imaging with flutemetamol F 18 PET/CTThis group includes all enrolled subjects (those with carotid disease and plans to undergo surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years old and plans for carotid endarterectomy.
Key exclusion criteria (7 listed)
- Patients with carotid occlusion will be excluded, due to one carotid contributing to both right and left brain blood supply.
- Other known sources of cardioembolism, including atrial fibrillation, mechanical heart valve, left atrial or ventricular thrombus or intracardiac mass, endocarditis, EF <30%
- Known stroke mimics including multiple sclerosis or brain tumor
- MRI contraindications per ACR guidelines, including patients with pacemakers, renal failure with eGFR<30 ml/min/1.73m2, and contrast allergy
- [18F]Flutemetamol contraindications per manufacturer guidelines, including patients with prior reactions
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 |
|---|---|---|
| Imaging with flutemetamol F 18 PET/CTAll subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT | Drug | Carotid atherosclerosis group |
Primary outcome
Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry.
Time frame: baseline
Carotid plaque inflammation will be calculated with quantitative immunohistochemistry and correlated with intraplaque hemorrhage while controlling for confounders.
Carotid MRI-detected intraplaque hemorrhage and prediction of brain inflammation on PET/CT.
Time frame: baseline
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.
Preoperative MRI-detected carotid intraplaque hemorrhage and prediction of cognitive improvement after endarterectomy.
Time frame: Change from baseline at 3 month followup
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.
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 13 May 2026.
- Individual participant dataSharing planned: 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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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.
Joseph S McNally, MD, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imaging with flutemetamol F 18 PET/CT in people with Cognitive Impairment and Carotid Artery Plaque, run by Scott Mcnally at 2 sites 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 1 inclusion and 7 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry. (time frame: baseline). The study lists 3 primary outcomes in all. 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 13 May 2026.