Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Healthy and HIV Associated Neurocognitive Disorder, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Preliminary data from the investigators' pilot study revealed SV2A PET imaging with radiotracer 11C-UCB-J identified regions of reduced synaptic density in suppressed PLWH compared to matched HIV-negative controls. PET and MRI imaging data will be processed for quantification of 11C-UCB-J imaging data in a larger group of suppressed PLWH compared to matched HIV-negative controls to test-retest reproducibility of 11C-UCB-J.
Conditions Studied
Interventions
- DRUG SV2A PET
- DRUG TSPO PET
Study Locations (1)
Connecticut
- Yale School of Medicne, Neuro ID Research Program - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
What NCT05586581 shows while recruiting
NCT05586581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05586581's enrollment target sits among peer trials
70 325th of 1090 higher than 759 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI