About this trial
The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and Female subjects must be ≥18 and <90 years of age;
Able to understand and provide informed consent prior to study procedures
Must be in good health
Less than 18 years of age;
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
[ 18F]3F4AP
DrugPET Scan #3
[18F]MK6240
DrugPET Scan #2
[11C]PIB
DrugPET Scan #1
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Tracers volume of distribution (VT)
PET images measured with \[ 18F\]3F4AP will quantify demyelination, those obtained with \[18F\]MK6240 will quantify tau burden and those obtained with \[11C\]PiB will reflect amyloid burden. PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers volume of distribution (VT).
Distribution volume ratio (DVR)
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers distribution volume ratio (DVR).
Binding potential (BPND)
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers binding potential (BPND).
Demyelination
\[18F\]3F4AP will be used to measure demyelination. On the MR images, after co-registration and alignment, signal from pre- and post-contrast T1-weighted images, T2-weighted image, ratio between T1- and T2-weighted images (T1/T2) will be calculated to assess demyelination and white matter lesion (WML) on MR sequences.
Secondary outcomes
Measure of brain atrophy
T1 images segmented and parcellated using FreeSurfer will be used to calculate cortical volumes, including the total cortical volume but also the hippocampal volume and will serve as proxies for neocortical and allocortical atrophy.
Measure of cerebrovascular burden
volume of White matter hyperintensities (WMH) on T1 images or T2 images
Measure of White matter lesions (WML)
The total WML load score will be calculated as the sum of the frequency of lesions multiplied by their volume.
MR/MRSI images
Evaluated to determine the effect of pulse sequence parameters and/or hardware configuration on image quality. The images acquired with different pulse sequence parameters or MR hardware configurations will be compared. Comparison of the MR images entails comparing the result of specific image quality measures such as signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) as well as the level of image artifacts
Sponsors and contacts
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Yale University
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
National Institute on Aging (NIA)
Collaborator