NCT04038840RecruitingPhase 1
Imaging Synapses With [11C] UCB-J in the Human Brain
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 29 Jul 2019
- Start date
- 1 Aug 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Davidzon, Guido, M.D.
- Diseases
- Schizophrenia
- NCT number
- NCT04038840
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 1 Aug 2019 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
Other illness
- Major medical neurological illness or significant head trauma
- History of or current claustrophobia
- For HC participants:
- Presence of a first degree relative with a psychotic disorder
- Lifetime diagnosis of major psychiatric illness
- For SZ participants:
- Unstable psychiatric symptoms at the time of testing, e.g. acute suicidality, prominent psychosis, or behavioral dyscontrol
Other
- Active substance use within three months of testing
- IQ \< 70
- Pregnancy or breastfeeding
- Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
- Inability to comply with basic study requirements such as following directions and punctuality
Who the study is looking for
- 18 - 65 years in age
- For SZ participants:
- On a stable medication regimen for at least two weeks prior to testing
- A clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
- Able to complete a PET-MR scan without the use of sedation
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Palo Alto Health Care System Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.