[18F]3F4AP Imaging for Multiple Sclerosis

Overseen By Kayla Cottiers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Anticoagulants

Disqualifiers: Pregnant, Breastfeeding, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

105 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Georges El Fakhri, PhD, DABR

Principal Investigator

Yale University

Eligibility Criteria

This trial is for healthy volunteers and individuals with conditions affecting brain or spinal cord myelin, such as mild cognitive impairment, Alzheimer's Disease, Multiple Sclerosis, Spinal Cord Injury, and Spinal Radiculopathy.

Inclusion Criteria

I am between 18 and 89 years old.

I understand the study and can give my consent.

Must be in good health

Exclusion Criteria

Pregnant or breastfeeding

Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months)

I do not have any serious illnesses or unstable health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Sessions

Participants undergo up to three PET scanning sessions to assess pharmacokinetics and demyelination

Varies per participant

Up to 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions

5 years

Treatment Details

Interventions

• [18F]3F4AP

Trial Overview The study tests the pharmacokinetics of three imaging compounds ([18F]3F4AP, [18F]MK6240, [11C]PIB) to assess their ability to visualize demyelination in various neurological conditions.

Participant Groups

Group I: Spinal radiculopathy (SR) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group II: Spinal Cord Injury (SCI) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group III: Multiple Sclerosis (MS) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group IV: Mild Cognitive Impairment (MCI) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group V: Alzheimer's Disease (AD) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group VI: Healthy Control Active Control 3 Interventions

n = 30 - up to three PET scanning sessions.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+