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Imaging for Cognitive Impairment
Phase 2
Waitlist Available
Led By Joseph S McNally, MD, PhD
Research Sponsored by Scott Mcnally
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
• Patients ≥18 years old and plans for carotid endarterectomy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3 month followup
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial will study whether there is a relationship between inflammation in the carotid artery and the brain, and whether this has an effect on cognition.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While this trial focuses on imaging rather than medication, side effects may include reactions to contrast agents used during PET/CT scans such as mild allergic reactions or discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 3 month followup
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 3 month followup
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Carotid MRI-detected intraplaque hemorrhage and prediction of brain inflammation on PET/CT.
Carotid intraplaque hemorrhage correlation with carotid plaque inflammation on immunohistochemistry.
Preoperative MRI-detected carotid intraplaque hemorrhage and prediction of cognitive improvement after endarterectomy.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Carotid atherosclerosis groupExperimental Treatment1 Intervention
This group includes all enrolled subjects (those with carotid disease and plans to undergo surgery).
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Who is running the clinical trial?
Scott McnallyLead Sponsor
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,142 Total Patients Enrolled
Joseph S McNally, MD, PhDPrincipal InvestigatorUniversity of Utah