Imaging for Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how certain imaging techniques can reveal inflammation in the carotid artery, a major blood vessel in the neck, and its effects on the brain. The goal is to determine if this inflammation links to brain inflammation and cognitive improvements after carotid surgery. The study employs a special PET/CT scan with a tracer called flutemetamol F 18 to identify these features. It seeks participants with carotid artery disease who plan to undergo surgery and do not have complete artery blockage or other specified conditions. Participants should be mindful of their heart and brain health, especially if they have a history of artery issues and are considering surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
What prior data suggests that this imaging method is safe for patients undergoing carotid surgery?
Research has shown that flutemetamol F 18, the imaging agent used in this trial, is generally safe for PET/CT scans. Studies have found that it effectively highlights amyloid plaques in the brain, often linked to memory and thinking problems like Alzheimer's disease.
Patients using flutemetamol F 18 are exposed to radiation, which is typical for imaging tests involving such agents. However, the radiation level remains low and is considered safe. The most common side effects are minor, including headaches, dizziness, and nausea.
This trial is in an early phase, indicating some evidence of safety, but further testing is needed for confirmation. The FDA has already approved flutemetamol F 18 for brain imaging related to cognitive decline, suggesting it is generally well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about imaging with flutemetamol F 18 PET/CT for cognitive impairment because it offers a unique way to visualize amyloid plaques in the brain, which are linked to conditions like Alzheimer's disease. Unlike traditional diagnostic methods that often rely on cognitive tests and MRI scans, this imaging technique uses a radioactive tracer to highlight these plaques, potentially allowing for earlier and more accurate detection. This could lead to timely interventions and more personalized treatment plans for individuals with cognitive impairment.
What evidence suggests that imaging with flutemetamol F 18 PET/CT is effective for cognitive impairment?
Research has shown that flutemetamol F 18 PET/CT scans effectively detect brain amyloid plaques, which are linked to memory and thinking problems. This imaging method can help predict the progression of conditions like mild cognitive impairment and Alzheimer's disease. Studies have found that using this scan can change the diagnosis for 20% of patients, highlighting its strong diagnostic value. In this trial, participants in the carotid atherosclerosis group will undergo flutemetamol imaging to explore how inflammation in neck arteries affects the brain, which could be important for predicting the benefits of neck artery surgery on brain health.678910
Who Is on the Research Team?
Joseph S McNally, MD, PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are scheduled to have carotid endarterectomy, a surgery on the arteries in their neck. It's not specified who can't join, but typically people with conditions that could interfere with the study or its results might be excluded.Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants undergo carotid MRI and PET scans to assess carotid and brain inflammation
Surgery and Immediate Postoperative Monitoring
Participants undergo carotid endarterectomy and are monitored for immediate postoperative outcomes
Follow-up
Participants are monitored for cognitive improvement and inflammation changes post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Imaging with flutemetamol F 18 PET/CT
Trial Overview
The study is testing if imaging of the carotid artery using flutemetamol F 18 PET/CT scans can predict inflammation in the artery wall, brain inflammation, and cognitive improvements after surgery.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
This group includes all enrolled subjects (those with carotid disease and plans to undergo surgery).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scott Mcnally
Lead Sponsor
American Heart Association
Collaborator
Citations
Clinical outcomes up to 9 years after [18F]flutemetamol ... - PMC
We aimed to investigate clinical outcomes up to 9 years after amyloid-PET to support the clinical validity of the imaging technique.
The Role of Large Artery Plaque Imaging Features in ...
This project will uncover links between inflamed carotid plaque and downstream brain inflammation. The invesigators will also determine carotid plaque imaging ...
3.
researchgate.net
researchgate.net/figure/Examples-of-FFlutemetamol-in-vivo-PET-CT-images-a-PET-CT-of-a-healthy-C57BL-6N_fig5_331888075Examples of [¹⁸F]Flutemetamol in vivo PET/CT images. (a) ...
High radioactivity is seen in the gallbladder (blue arrows), intestine (red arrows), and urinary bladder (yellow arrows). The kidneys are also faintly visible.
4.
itnonline.com
itnonline.com/content/data-demonstrates-f-18-flutemetamol-pet-indicates-progression-amnestic-mild-cognitiveData Demonstrates F-18 Flutemetamol PET Indicates ...
A positive [18F]flutemetamol positron emission tomography (PET) scan for brain amyloid was a highly significant predictor of progression from amnestic Mild ...
Carotid Endarterectomy Ameliorates Cognitive Impairment ...
All patients underwent molecular imaging with 18F‐FDG PET/MRI, neurological and cognitive examinations, and CEA measurement. Cognitive function ...
18F PET with flutemetamol for the early diagnosis of ... - PMC
18 F‐flutemetamol to predict the progression from MCI to Alzheimer's disease dementia (ADD) or other dementias has not yet been systematically evaluated.
VIZAMYLTM (flutemetamol F 18 injection), for intravenous use
A negative scan indicates sparse to no neuritic plaques. In patients being evaluated for AD and other causes of cognitive decline who have not been treated with ...
What are the side effects of Flutemetamol F-18?
Another potential side effect is the exposure to radiation, intrinsic to any radiopharmaceutical substance. Although the level of radiation used ...
Amyloid-Targeting PET Tracer [18F]Flutemetamol ...
[ 18 F]Flutemetamol binds to amyloid-positive areas in human atherosclerotic plaques. Further studies are warranted to clarify the uptake mechanisms.
Ultralow Dose PET Imaging of 18F-Florbetapir ...
18F-Florbetapir and 18F-Flutemetamol are often found to be taken up at higher levels in Alzheimer's disease, mild cognitive impairment, other forms of dementia.
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