Demyelinating DisordersPhase 1NCT06999434
Exploring the Utility of [18F]3F4AP for Demyelination Imaging
A Phase 1 study testing [ 18F]3F4AP, [18F]MK6240 and [11C]PIB in people with Demyelinating Disorders and MCI, run by Yale University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Demyelinating Disorders, MCI, Alzheimer's Disease (AD)
- What is being tested?
- [ 18F]3F4AP, [18F]MK6240 and [11C]PIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 5 May 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years of age;
- Pregnant or breastfeeding;
- Any significant systemic illness or unstable medical condition;
- Pre-existing medical conditions or claustrophobic reactions;
- Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
- History of a bleeding disorder or are currently taking anticoagulants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University PET Center
New Haven, Connecticut, 06510
About this study
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).
- Conditions
- Demyelinating Disorders, MCI, Alzheimer's Disease (AD), MS (Multiple Sclerosis), SCI - Spinal Cord Injury, Spinal Radiculopathy
- Being tested
- [ 18F]3F4AP, [18F]MK6240, [11C]PIB
- Keywords
- 3F4AP, Demyelinating Disorders, MS, SCI, AD
- Medical subject headings
- Demyelinating Diseases, Alzheimer Disease, Multiple Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[ 18F]3F4APDrug
PET Scan #3
[18F]MK6240Drug
PET Scan #2
[11C]PIBDrug
PET Scan #1
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Active comparator | n = 30 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
| Alzheimer's Disease (AD) | Experimental | n = 15 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
| Mild Cognitive Impairment (MCI) | Experimental | n = 15 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
| Multiple Sclerosis (MS) | Experimental | n = 15 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
| Spinal Cord Injury (SCI) | Experimental | n = 15 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
| Spinal radiculopathy (SR) | Experimental | n = 15 - up to three PET scanning sessions. Receives: Drug: [ 18F]3F4AP; Drug: [18F]MK6240; Drug: [11C]PIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 5 years
Binding potential (BPND)
PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers binding potential (BPND).
Measured: 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.
Measured: 5 years
Tau burden
[18F]MK6240 will be used to measure Tau burden.
Measured: 5 years
Amyloid burden
[11C]PiB will reflect amyloid burden.
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (4)
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.
Measured: 5 years
Measure of cerebrovascular burden
volume of White matter hyperintensities (WMH) on T1 images or T2 images
Measured: 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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start5 May 2025
- Primary completion5 May 2030 (estimated)
- Study completion5 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Georges El Fakhri, Yale University
- Investigators
- Georges El Fakhri, PhD, DABR, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999434
- Sponsor's protocol ID
- 2000039282
- Other IDs
- 7P41EB022544-08, 7R01EB033582-03, 7R01AG076153-03, 1R01AG085561-01
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility of [18F]3F4AP for Demyelination Imaging
- ClinicalTrials.gov ID
- NCT06999434
- Acronym / sponsor ID
- 2000039282
- Conditions
- Demyelinating Disorders, MCI, Alzheimer's Disease (AD), MS (Multiple Sclerosis), SCI - Spinal Cord Injury, Spinal Radiculopathy
- Keywords
- 3F4AP, Demyelinating Disorders, MS, SCI, AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute on Aging (NIA)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 May 2030 (estimated)
- Study completion
- 5 May 2030 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Active comparator | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 30 - up to three PET scanning sessions. |
| Alzheimer's Disease (AD) | Experimental | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 15 - up to three PET scanning sessions. |
| Mild Cognitive Impairment (MCI) | Experimental | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 15 - up to three PET scanning sessions. |
| Multiple Sclerosis (MS) | Experimental | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 15 - up to three PET scanning sessions. |
| Spinal Cord Injury (SCI) | Experimental | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 15 - up to three PET scanning sessions. |
| Spinal radiculopathy (SR) | Experimental | Drug: [ 18F]3F4AP, Drug: [18F]MK6240, Drug: [11C]PIBn = 15 - up to three PET scanning sessions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Less than 18 years of age;
- Pregnant or breastfeeding;
- Any significant systemic illness or unstable medical condition;
- Pre-existing medical conditions or claustrophobic reactions;
- Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [ 18F]3F4APPET Scan #3 | Drug | Alzheimer's Disease (AD), Healthy Control, Mild Cognitive Impairment (MCI), Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Spinal radiculopathy (SR) |
| [18F]MK6240PET Scan #2 | Drug | Alzheimer's Disease (AD), Healthy Control, Mild Cognitive Impairment (MCI), Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Spinal radiculopathy (SR) |
| [11C]PIBPET Scan #1 | Drug | Alzheimer's Disease (AD), Healthy Control, Mild Cognitive Impairment (MCI), Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Spinal radiculopathy (SR) |
Primary outcome
Tracers volume of distribution (VT)
Time frame: 5 years
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)
Time frame: 5 years
PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers distribution volume ratio (DVR).
Binding potential (BPND)
Time frame: 5 years
PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers binding potential (BPND).
Demyelination
Time frame: 5 years
[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.
Tau burden
Time frame: 5 years
[18F]MK6240 will be used to measure Tau burden.
Amyloid burden
Time frame: 5 years
[11C]PiB will reflect amyloid burden.
Tracer rate constant
Time frame: 5 years
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.
Associations between imaging modalities and biomarkers.
Time frame: 5 years
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.
4 secondary outcomes
Measure of brain atrophy
Time frame: 5 years
Measure of cerebrovascular burden
Time frame: 5 years
Measure of White matter lesions (WML)
Time frame: 5 years
MR/MRSI images
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georges El Fakhri, PhD, DABR principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [ 18F]3F4AP, [18F]MK6240 and [11C]PIB in people with Demyelinating Disorders and MCI, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannan Henry (+1 (203) 737-5278, shannan.henry@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracers volume of distribution (VT) (time frame: 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.