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Imaging Synapses With [11C] UCB-J in the Human Brain

NCT04038840 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

[11C]UCB-J radiotracer

I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein

DEVICE

PET-MR

Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes

Sponsors & Collaborators

  • Weston Havens Foundation

    collaborator UNKNOWN

  • Davidzon, Guido, M.D.

    lead OTHER

Principal Investigators

  • Jong H Yoon, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038840 on ClinicalTrials.gov