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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Davidzon, Guido, M.D.
Study ID
NCT04038840
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • [11C]UCB-J radiotracer — DRUG
    I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein
  • PET-MR — DEVICE
    Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Healthy Control (HC) Participants
    Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer
  • Experimental: Schizophrenia (SZ) Participants
    Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer

Primary Outcome Measure

Cross-sectional differences in synaptic density between HC and SZ participants [ Time Frame: 120 minutes (scan duration) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304-
Stanford UniversityStanfordCalifornia94305-

Find similar trials in Palo Alto, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Palo Alto Health Care System· Palo Alto, CAStanford University· Stanford, CA

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