Exploring the Utility of [18F]3F4AP for Demyelination Imaging

Yale University

Status and phase: Enrolling; Phase 1

Conditions: MCI; SCI - Spinal Cord Injury; Alzheimer's Disease (AD); Spinal Radiculopathy; Demyelinating Disorders; MS (Multiple Sclerosis)

Treatments: Drug: [ 18F]3F4AP; Drug: [11C]PIB; Drug: [18F]MK6240

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06999434

7P41EB022544-08 (U.S. NIH Grant/Contract)

1R01AG085561-01 (U.S. NIH Grant/Contract)

2000039282

7R01AG076153-03 (U.S. NIH Grant/Contract)

7R01EB033582-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 6 patient groups

Healthy Control

Active Comparator group

Description:

n = 30 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240

Alzheimer's Disease (AD)

Experimental group

Description:

n = 15 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240

Mild Cognitive Impairment (MCI)

Experimental group

Description:

n = 15 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240

Multiple Sclerosis (MS)

Experimental group

Description:

n = 15 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240

Spinal Cord Injury (SCI)

Experimental group

Description:

n = 15 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240

Spinal radiculopathy (SR)

Experimental group

Description:

n = 15 - up to three PET scanning sessions.

Treatment:

Drug: [ 18F]3F4AP

Drug: [11C]PIB

Drug: [18F]MK6240