A Phase 1 interventional study of [ 18F]3F4AP and [18F]MK6240 in Demyelinating Disorders, MCI and Alzheimer's Disease (AD), sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Yale University · Phase 1, Interventional, and Diagnostic
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).
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 105 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Multiple Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Demyelinating Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
n = 30 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
n = 15 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
n = 15 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
n = 15 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
n = 15 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
n = 15 - up to three PET scanning sessions.
Drug: [ 18F]3F4AP · Drug: [18F]MK6240 · Drug: [11C]PIB
PET Scan #3
PET Scan #2
Drug pages: PIB C-11 · Pittsburgh compound B
PET Scan #1
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).
Time frame: 5 years
Distribution volume ratio (DVR)
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers distribution volume ratio (DVR).
Time frame: 5 years
Binding potential (BPND)
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers binding potential (BPND).
Time frame: 5 years
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.
Time frame: 5 years
Tau burden
\[18F\]MK6240 will be used to measure Tau burden.
Time frame: 5 years
Amyloid burden
\[11C\]PiB will reflect amyloid burden.
Time frame: 5 years
Tracer rate constant
The tracer rate constant for transfer from arterial plasma to tissue K1 and relative delivery R1 will also be estimated using tracer kineticmodeling technique, to provide measures of cerebral perfusion or CBF.
Time frame: 5 years
Associations between imaging modalities and biomarkers.
The Pearson correlation coefficient r will be used to assess the strength of the linear correlations between outcome measures. A P value of 0.05 or less will be considered statistically significant.
Time frame: 5 years
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.
Time frame: 5 years
Measure of cerebrovascular burden
volume of White matter hyperintensities (WMH) on T1 images or T2 images
Time frame: 5 years
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.
Time frame: 5 years
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
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2030, 60 months after the start.
Of 53 non-industry phase 1 interventional studies under Multiple Sclerosis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 71. This study's planned 60 months is above that.
Counting every sponsor, half of 91 studies reached it within 30 months; a quarter within 9 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.