NCT04038840

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Davidzon, Guido, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Schizophrenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-07-31
• Last updated: 2024-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study