Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04038840

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

Led by Davidzon, Guido, M.D. · Updated on 2024-12-16

60

Participants Needed

2

Research Sites

330 weeks

Total Duration

On this page

Sponsors

D

Davidzon, Guido, M.D.

Lead Sponsor

W

Weston Havens Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • For schizophrenia participants: on a stable medication regimen for at least two weeks before testing
  • For schizophrenia participants: clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
  • For schizophrenia participants: able to complete a PET-MR scan without sedation
Not Eligible

You will not qualify if you...

  • Active substance use within three months before testing
  • IQ less than 70
  • Major medical neurological illness or significant head trauma
  • Pregnancy or breastfeeding
  • Contraindications to MR scanning, including incompatible metal or devices such as pacemakers or cochlear implants
  • Weight over 350 lbs or body size that cannot fit in the MR scanner
  • History or current claustrophobia
  • Inability to follow study requirements such as directions and punctuality
  • For healthy controls: presence of a first-degree relative with a psychotic disorder
  • For healthy controls: lifetime diagnosis of major psychiatric illness
  • For schizophrenia participants: unstable psychiatric symptoms at testing, including acute suicidality, prominent psychosis, or behavioral dyscontrol

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

VA Palo Alto Health Care System

Palo Alto, California, United States, 94304

Actively Recruiting

2

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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