We aim to use quantitative [18F]Florbetaben PET to investigate a potential lateralized distribution of cerebral amyloid-β deposition in patients with COD. To validate the assumption that the hypoperfusion is lateralized, we use relative…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint is the difference in [18F]Florbetaben binding potential (BPnd)
between the affected hemisphere and the contralateral hemisphere. Second
endpoint is the difference in perfusion between hemispheres, using the
parametric images of relative trace flow (R1).
Secondary outcome
Secundary outcome measures are the relationship between amyloid-β deposition
and relative perfusion (R1), the relationship between amyloid-β deposition and
relative perfusion to cognitive functioning and the relationship between
amyloid-β deposition and relative perfusion to structural neuroimaging
parameters (i.e. vascular brain injury and atrophy) in patients with COD.
Background summary
Carotid occlusive disease (COD) is a risk factor for cognitive decline. Athero-
and arteriosclerosis of the cerebral arteries may cause hypoperfusion in the
brain. Cerebral hypoperfusion may be one of the factors contributing to the
accelerated deposition of amyloid-β in the brain parenchyma or vasculature,
which in turn may contribute to the observed cognitive decline. With position
emission tomography (PET), it is possible to quantify the amyloid-β plaque
distribution pattern in vivo. We hypothesize that in patients with COD,
amyloid-β burden is lateralized towards the hemisphere where the occlusion
takes place. In the present study, we investigate whether the distribution of
amyloid-β deposition is lateralized in patients with unilateral COD, using
quantitative measurements of amyloid with PET.
Study objective
We aim to use quantitative [18F]Florbetaben PET to investigate a potential
lateralized distribution of cerebral amyloid-β deposition in patients with COD.
To validate the assumption that the hypoperfusion is lateralized, we use
relative perfusion (R1) derived from pharmokinetic modeling of the dynamic
amyloid PET to investigate differences in perfusion between hemispheres.
Secondary objectives: We aim to study the association between deposition and
relative perfusion (R1) and between both amyloid-β binding and R1 and clinical
measures (cognitive functioning and neuroimaging parameters).
Study design
Cross-sectional, observational study, within subjects.
Study burden and risks
Risks associated with participation in this study are related to 1) radiation
exposure, 2) idiosyncratic reaction to the tracer, and 3) placement of
intra-venous catheters.
Heidelberglaan 100
Utrecht 3574 CX
NL
Heidelberglaan 100
Utrecht 3574 CX
NL
Listed location countries
Age
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;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72646.041.20 |