Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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).