Amyloid PET in patients with carotid occlusive disease

Completed

• Conditions: Carotid occlusive disease; 10029305

• Registration Number: NL-OMON49144
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-02-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

In order to be eligible to participate in this study, a patient must meet all
of the following criteria:
- At least 55 years of age;
- Occlusion of the internal carotid artery (ICA) as visible on MR or CT
angiography, or DSA;
- Mini-mental state examination (MMSE) is higher or equal to 18;
- Patients must, in the opinion of the principal investigator/attending
neurologist, be able to tolerate the [18F]Florbetaben PET scan procedures and
be competent to make a well in-formed decision to participate in this study;

Exclusion Criteria

A potential patient who meets any of the following criteria will be excluded
from participation in this study:
- Contralateral stenosis of >70% of the ICA or middle cerebral artery (MCA);
- History of vascular reconstructive surgery in the brain;
- Has evidence of structural abnormalities such as mass on MRI that is likely
to interfere with the clinical presentation and/or interpretation of PET scan;
- Has ever participated in an experimental study with an amyloid targeting
agent, unless it can be documented that the subject received only placebo
during the course of the trial;
- Has been injected with a previously administered radiopharmaceutical within 6
months terminal half-lives OR when the total yearly radiation exposure exceeds
10 mSv;
- Has other neurological diagnosis, such as Parkinson*s disease, multiple
sclerosis or severe traumatic brain injury, or a major psychiatric disorder;

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint is the difference in [18F]Florbetaben binding potential (BPnd)<br /><br>between the affected hemisphere and the contralateral hemisphere. Second<br /><br>endpoint is the difference in perfusion between hemispheres, using the<br /><br>parametric images of relative trace flow (R1). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measures are the relationship between amyloid-&beta; deposition<br /><br>and relative perfusion (R1), the relationship between amyloid-&beta; deposition and<br /><br>relative perfusion to cognitive functioning and the relationship between<br /><br>amyloid-&beta; deposition and relative perfusion to structural neuroimaging<br /><br>parameters (i.e. vascular brain injury and atrophy) in patients with COD. </p><br>