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

NCT ID: NCT04038840

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Control (HC) Participants

Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer

Group Type EXPERIMENTAL

[11C]UCB-J radiotracer

Intervention Type DRUG

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

PET-MR

Intervention Type DEVICE

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

Schizophrenia (SZ) Participants

Participants will undergo positron emission tomography-magnetic resonance (PET-MR) imaging using the \[11C\]UCB-J radiotracer

Group Type EXPERIMENTAL

[11C]UCB-J radiotracer

Intervention Type DRUG

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

PET-MR

Intervention Type DEVICE

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

Interventions

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[11C]UCB-J radiotracer

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

Intervention Type DRUG

PET-MR

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Active substance use within three months of testing
* IQ \< 70
* Major medical neurological illness or significant head trauma
* Pregnancy or breastfeeding
* Contraindication to MR scanning, including magnetic-resonance incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ
* Weight \> 350 lbs or a large body habitus that MR scanner cannot accommodate
* History of or current claustrophobia
* Inability to comply with basic study requirements such as following directions and punctuality
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weston Havens Foundation

UNKNOWN

Sponsor Role collaborator

Davidzon, Guido, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Jong Yoon

Associate Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong H Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Coordinator

Role: CONTACT

Phone: 650-849-0552

Email: [email protected]

References

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Chong HY, Teoh SL, Wu DB, Kotirum S, Chiou CF, Chaiyakunapruk N. Global economic burden of schizophrenia: a systematic review. Neuropsychiatr Dis Treat. 2016 Feb 16;12:357-73. doi: 10.2147/NDT.S96649. eCollection 2016.

Reference Type BACKGROUND
PMID: 26937191 (View on PubMed)

Finnema SJ, Nabulsi NB, Eid T, Detyniecki K, Lin SF, Chen MK, Dhaher R, Matuskey D, Baum E, Holden D, Spencer DD, Mercier J, Hannestad J, Huang Y, Carson RE. Imaging synaptic density in the living human brain. Sci Transl Med. 2016 Jul 20;8(348):348ra96. doi: 10.1126/scitranslmed.aaf6667.

Reference Type BACKGROUND
PMID: 27440727 (View on PubMed)

Sekar A, Bialas AR, de Rivera H, Davis A, Hammond TR, Kamitaki N, Tooley K, Presumey J, Baum M, Van Doren V, Genovese G, Rose SA, Handsaker RE; Schizophrenia Working Group of the Psychiatric Genomics Consortium; Daly MJ, Carroll MC, Stevens B, McCarroll SA. Schizophrenia risk from complex variation of complement component 4. Nature. 2016 Feb 11;530(7589):177-83. doi: 10.1038/nature16549. Epub 2016 Jan 27.

Reference Type BACKGROUND
PMID: 26814963 (View on PubMed)

Nabulsi NB, Mercier J, Holden D, Carre S, Najafzadeh S, Vandergeten MC, Lin SF, Deo A, Price N, Wood M, Lara-Jaime T, Montel F, Laruelle M, Carson RE, Hannestad J, Huang Y. Synthesis and Preclinical Evaluation of 11C-UCB-J as a PET Tracer for Imaging the Synaptic Vesicle Glycoprotein 2A in the Brain. J Nucl Med. 2016 May;57(5):777-84. doi: 10.2967/jnumed.115.168179. Epub 2016 Feb 4.

Reference Type BACKGROUND
PMID: 26848175 (View on PubMed)

Feinberg I. Schizophrenia: caused by a fault in programmed synaptic elimination during adolescence? J Psychiatr Res. 1982-1983;17(4):319-34. doi: 10.1016/0022-3956(82)90038-3.

Reference Type BACKGROUND
PMID: 7187776 (View on PubMed)

Finnema SJ, Nabulsi NB, Mercier J, Lin SF, Chen MK, Matuskey D, Gallezot JD, Henry S, Hannestad J, Huang Y, Carson RE. Kinetic evaluation and test-retest reproducibility of [11C]UCB-J, a novel radioligand for positron emission tomography imaging of synaptic vesicle glycoprotein 2A in humans. J Cereb Blood Flow Metab. 2018 Nov;38(11):2041-2052. doi: 10.1177/0271678X17724947. Epub 2017 Aug 9.

Reference Type BACKGROUND
PMID: 28792356 (View on PubMed)

Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836.

Reference Type BACKGROUND
PMID: 30014145 (View on PubMed)

Wu Y, Carson RE. Noise reduction in the simplified reference tissue model for neuroreceptor functional imaging. J Cereb Blood Flow Metab. 2002 Dec;22(12):1440-52. doi: 10.1097/01.WCB.0000033967.83623.34.

Reference Type BACKGROUND
PMID: 12468889 (View on PubMed)

Other Identifiers

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46106

Identifier Type: -

Identifier Source: org_study_id