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NCT05586581 · ClinicalTrials.gov registry record · Phase 1

SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy

A Phase 1 study of Healthy and HIV Associated Neurocognitive Disorder, sponsored by Yale University.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT05586581 is a Phase 1 study of Healthy and HIV Associated Neurocognitive Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 70 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05586581, a Phase 1 study of Healthy and HIV Associated Neurocognitive Disorder, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers \[11C\]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET \[11C\]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).

Conditions Studied

Healthy HIV Associated Neurocognitive Disorder HIV Dementia HIV Encephalitis

Interventions

  • DRUG SV2A PET
  • DRUG TSPO PET

Study Locations (1)

Connecticut

  • Yale School of Medicne, Neuro ID Research Program - New Haven

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-05-17
Est. Completion 2030-12
Phase Phase 1

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT05586581

The ClinicalTrials.gov registry entry for NCT05586581 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which SV2A PET is the first listed.

NCT05586581 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT05586581 about?

NCT05586581 is a clinical study titled "SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy". The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. ...

What is the current status of trial NCT05586581?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2023-05-17. Estimated completion is 2030-12.

What conditions does trial NCT05586581 study?

This clinical trial studies the following conditions: Healthy, HIV Associated Neurocognitive Disorder, HIV Dementia, HIV Encephalitis.

What interventions are being tested in trial NCT05586581?

The interventions under investigation include: SV2A PET (DRUG), TSPO PET (DRUG).

Who is sponsoring clinical trial NCT05586581?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05586581 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.