Recruiting
Phase 1

\[18F\]3F4AP

Sponsor:

Yale University

Code:

NCT06999434

Conditions

Demyelinating Disorders

MCI

Alzheimer's Disease (AD)

MS (Multiple Sclerosis)

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[ 18F]3F4AP

[18F]MK6240

[11C]PIB

Study Details

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).

Conditions

Demyelinating Disorders

MCI

Alzheimer's Disease (AD)

MS (Multiple Sclerosis)

SCI - Spinal Cord Injury

Study ID

NCT06999434

Start date

May 5, 2025

Status verified date

Sep, 2026

Completion date

May 5, 2030

Anticipated

Primary completion date

May 5, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy Control

n = 30 - up to three PET scanning sessions.

experimental: Alzheimer's Disease (AD)

n = 15 - up to three PET scanning sessions.

experimental: Mild Cognitive Impairment (MCI)

n = 15 - up to three PET scanning sessions.

experimental: Multiple Sclerosis (MS)

n = 15 - up to three PET scanning sessions.

experimental: Spinal Cord Injury (SCI)

n = 15 - up to three PET scanning sessions.

experimental: Spinal radiculopathy (SR)

n = 15 - up to three PET scanning sessions.

Interventions

[ 18F]3F4AP

PET Scan #3

[18F]MK6240

PET Scan #2

[11C]PIB

PET Scan #1

Primary outcome measure

  • Tracers volume of distribution (VT) [ Time Frame: 5 years ]
  • Distribution volume ratio (DVR) [ Time Frame: 5 years ]
  • Binding potential (BPND) [ Time Frame: 5 years ]
  • Demyelination [ Time Frame: 5 years ]
  • Tau burden [ Time Frame: 5 years ]
  • Amyloid burden [ Time Frame: 5 years ]
  • Tracer rate constant [ Time Frame: 5 years ]
  • Associations between imaging modalities and biomarkers. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Shannan Henry

+1 (203) 737-5278shannan.henry@yale.edu

Kayla Cottiers

203-737-7496kayla.cottiers@yale.edu

Locations

Yale University PET Center

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • 3F4AP
  • Demyelinating Disorders
  • MS
  • SCI
  • AD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-09.