Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

NCT04710550 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2020P002254
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to obtain an initial assessment of the value of using \[18F\]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD):

• Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events.
• Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits.
• Aim 3) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas.
• Aim 4) Correlate MR images with \[18F\]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all.
• Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).

Conditions

Brain Injuries, Traumatic; Demyelinating Disorder; Alzheimer Disease

Keywords

3F4AP

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Determine number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5 years

Study Arms (4)

Safety/Dosimetry Cohort

EXPERIMENTAL

Drug: F18-3F4AP

Traumatic Brain Injury

EXPERIMENTAL

Drug: F18-3F4AP

AD/MCI

EXPERIMENTAL

Drug: F18-3F4AP

Healthy Controls

ACTIVE COMPARATOR

Drug: F18-3F4AP

Interventions

F18-3F4AP DRUG

PET Scan

AD/MCI; Healthy Controls; Safety/Dosimetry Cohort; Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are 18 years of age and older, except AD subjects who are 60 to 90 years of age.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Ramos-Torres K, Sun Y, Takahashi K, Zhou YP, Brugarolas P. Common anesthetic used in preclinical PET imaging inhibits metabolism of the PET tracer [18F]3F4AP. J Neurochem. 2024 Sep;168(9):2577-2586. doi: 10.1111/jnc.16118. Epub 2024 May 1.

  PMID: 38690718 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Demyelinating Diseases; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marc Normandin, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 14, 2021
• Study Start: January 25, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)