NCT06999434 Exploring the Utility of [18F]3F4AP for Demyelination Imaging
| NCT ID | NCT06999434 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Demyelinating Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2030-05-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 105 participants in total. It began in 2025-05-05 with a primary completion date of 2030-05-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion: 1. Male and Female subjects must be ≥18 and \<90 years of age; 2. Able to understand and provide informed consent prior to study procedures 3. Must be in good health Exclusion: 1. Less than 18 years of age; 2. Pregnant or breastfeeding; 3. Any significant systemic illness or unstable medical condition; 4. Pre-existing medical conditions or claustrophobic reactions; 5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months); 6. History of a bleeding disorder or are currently taking anticoagulants.
Contact & Investigator
Georges El Fakhri, PhD, DABR
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06999434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Demyelinating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06999434 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06999434 currently recruiting?
Yes, NCT06999434 is actively recruiting participants. Contact the research team at shannan.henry@yale.edu for enrollment information.
Where is the NCT06999434 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06999434 clinical trial?
NCT06999434 is sponsored by Yale University. The principal investigator is Georges El Fakhri, PhD, DABR at Yale University. The trial plans to enroll 105 participants.