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NCT01894646 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of Extrathalamic α4β2-nicotinic Acetylcholine Receptors in Health and Disease With [18F]XTRA
A Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01894646: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT01894646 is a Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01894646, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Currently, only three radiotracers, (2-\[18F\]FA, 6-\[18F\]FA and \[18F\]AZAN), are available for studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET imaging. A crucial problem for 2-\[18F\] FA, 6-\[18F\] FA and (\[18F\] AZAN is low binding potential (BP) in extrathalamic (ET) regions, including hippocampus, cortex and caudate which have lower receptor densities than the thalamus. The importance of imaging ET-α4β2-nAChRs (ET-nAChR) has emerged from the post-mortem demonstration of altered densities of ET-nAChRs (but not thalamic nAChR) in neurodegenerative diseases and schizophrenia. PET imaging of ET-nAChR may prove to be useful in both detecting early changes and following functional deterioration in neurodegenerative diseases such as Alzheimers disease. Furthermore, PET imaging of ET-nAChR may allow investigation and development of new therapies acting on the acetylcholine system. The imaging drawbacks of the presently available nAChR radioligands have initiated the development of radioligands with greater binding potential by several research groups. The available pre-clinical data on the investigators' new radioligand \[18F\](-)-JHU86428 (\[18F\]XTRA) suggest that this radioligand is superior to 2-\[18F\]FA for quantitative PET imaging of α4β2-nAChR (Gao, J. Med. Chem, 2008). In baboon PET studies \[18F\]XTRA exhibits 200% greater brain uptake, 300% higher BPs and reaches steady-state in approximately 1.5 h in cortical regions post-bolus administration versus 6-8 h for 2-\[18F\]FA. In vitro binding assays shows greater binding affinity of XTRA and similar nAChR-subtype selectivity in comparison with 2-FA. Both ligands bind selectively with the β2-subtypes that are predominant nAChR subtypes in the mammal brain and display little binding affinity at ganglionic α3β4-nAChR. The current planned human protocol will be conducted to (1) determine brain distribution (brain uptake) and test the reproducibility (in test-retest design)
Interventions
- RADIATION Positron Emission Tomography (PET) Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-02 |
| Est. Completion | 2021-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894646
The ClinicalTrials.gov registry entry for NCT01894646 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Positron Emission Tomography (PET) Imaging is the first listed.
NCT01894646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01894646 about?
NCT01894646 is a clinical study titled "PET Imaging of Extrathalamic α4β2-nicotinic Acetylcholine Receptors in Health and Disease With [18F]XTRA". Currently, only three radiotracers, (2-\[18F\]FA, 6-\[18F\]FA and \[18F\]AZAN), are available for studying α4β2-nicotinic acetylcholine receptors (α4β2-nAChR) in human brain using PET imaging. A crucial problem for 2-\[18F\] FA, 6-\[18F\] FA and (\[18F\] AZAN is low binding potential (BP) in extrath...
What is the current status of trial NCT01894646?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2013-02. Estimated completion is 2021-06.
What interventions are being tested in trial NCT01894646?
The interventions under investigation include: Positron Emission Tomography (PET) Imaging (RADIATION).
Who is sponsoring clinical trial NCT01894646?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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