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NCT04038840 · ClinicalTrials.gov registry record · Phase 1
Imaging Synapses With [11C] UCB-J in the Human Brain
A Phase 1 study of Schizophrenia, sponsored by Davidzon, Guido, M.D..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04038840: Recruiting Phase 1 study of Schizophrenia, sponsored by Davidzon, Guido, M.D..
NCT04038840 is a Phase 1 study of Schizophrenia that is actively recruiting participants, run by Davidzon, Guido, M.D.. The registered enrollment target is 60 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04038840, a Phase 1 study of Schizophrenia, is actively recruiting participants, sponsored by Davidzon, Guido, M.D..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by \[11C\]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.
Primary Outcome
Synaptic density will be quantified with the regional binding potential (BP\_ND), a measure of \[11C\]UCB-J binding. BP\_ND will be derived by using the simplified reference tissue model 2 (Wu \& Carson, 2002) and the centrum semiovale as the reference region. This method has been recently utilized by other investigators in neuropsychiatric samples (Chen et al., 2018). Both exploratory voxel-wise BP\_ND and region of interest (ROI) BP\_ND will be compared across groups. ROIs include the striatum
Conditions Studied
Interventions
- DRUG [11C]UCB-J radiotracer
- DEVICE PET-MR
Study Locations (2)
California
- VA Palo Alto Health Care System - Palo Alto
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT04038840 shows while recruiting
NCT04038840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which [11C]UCB-J radiotracer is the first listed.
NCT04038840 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04038840 about?
NCT04038840 is a clinical study titled "Imaging Synapses With [11C] UCB-J in the Human Brain". The purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer \[11C\]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ab...
What is the current status of trial NCT04038840?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-08-01. Estimated completion is 2025-12.
What conditions does trial NCT04038840 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT04038840?
The interventions under investigation include: [11C]UCB-J radiotracer (DRUG), PET-MR (DEVICE).
Who is sponsoring clinical trial NCT04038840?
This trial is sponsored by Davidzon, Guido, M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04038840 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
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 NCT04038840's enrollment target sits among peer trials
60 188th of 315 higher than 119 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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
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