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NCT02108015 · ClinicalTrials.gov registry record · Phase 1
Evaluation of a Novel Positron Emission Tomography (PET Radiotracer for TARP Gamma-8
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02108015 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 6 participants.
The verdict
NCT02108015, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Objective Ionotropic glutamate receptors are ligand-gated ion channels responsible for most of the excitatory neurotransmission in the mammalian central nervous system (CNS). Based on pharmacology, they have been grouped into three subtypes-NMDA, AMPA and kainate. In recent years it has become apparent that the receptors do not function alone, but in the company of auxiliary proteins that regulate their activity \[1\]. Some of these have been shown to modulate AMPA receptor trafficking, gating and pharmacology and are classified as transmembrane AMPA receptor regulatory proteins, or TARPs ( \>=-2, \>=-3, \>=-4, \>=-5, \>=-7, and \>=-8). Genetic data indicate a possible role of TARPs in schizophrenia, depression, epilepsy, neuropathic pain, and bipolar disorder \[1\]. In a preclinical collaboration with Eli Lilly, we developed a promising radioligand, 18F-TARP252 to image TARP \>=-8 using positron emission tomography (PET). This protocol covers three phases: * Phase 1: kinetic brain imaging to quantify TARP \>=-8 in brain relative to concurrent measurement of the parent radioligand in arterial plasma; * Phase 2: if 18F-TARP252 is successful in Phase 1, we will estimate the radiation-absorbed doses by performing whole body imaging; * Phase 3: test-retest analysis of brain binding relative to concurrent measurement of the parent radioligand in arterial plasma. Study Population Healthy adult female and male volunteers (n=22, ages 18 - 55) will undergo brain imaging. An additional eight healthy volunteers will undergo whole body dosimetry analysis. Design For quantification of TARP \>=-8, 22 healthy controls will have brain PET imaging using 18F-TARP252 and an arterial line. Some of them will have a test-retest scan. Eight additional subjects will have a whole body PET scan for dosimetry. For dosimetry, no arterial line will be used. Outcome Measures To assess quantitation of TARP \>=-8 with 18F-TARP252, we will primarily use two outcome measures: the identifiab
Interventions
- PROCEDURE Blood Sampling
- PROCEDURE Brain Imaging (PET)
- PROCEDURE Aterial Line
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-03-05 |
| Est. Completion | 2016-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108015
The ClinicalTrials.gov registry entry for NCT02108015 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blood Sampling is the first listed.
NCT02108015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02108015 about?
NCT02108015 is a clinical study titled "Evaluation of a Novel Positron Emission Tomography (PET Radiotracer for TARP Gamma-8". Objective Ionotropic glutamate receptors are ligand-gated ion channels responsible for most of the excitatory neurotransmission in the mammalian central nervous system (CNS). Based on pharmacology, they have been grouped into three subtypes-NMDA, AMPA and kainate. In recent years it has become appa...
What is the current status of trial NCT02108015?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-03-05. Estimated completion is 2016-12-01.
What interventions are being tested in trial NCT02108015?
The interventions under investigation include: Blood Sampling (PROCEDURE), Brain Imaging (PET) (PROCEDURE), Aterial Line (PROCEDURE).
Who is sponsoring clinical trial NCT02108015?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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