Effects of Adolescent Synaptic Pruning

NCT07569718 | Enrolling By Invitation

• 2 other identifiers: STUDY240600233R01MH067924-19S1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study will use a PET-based measure of brain cell (neuron) connections (synapses) in young adults who have also obtained an MRI, to assess how the loss of brain cell connections (synaptic pruning) is captured by MRI-based measures. This will inform youth MRI studies to understand neurotypical brain development that can help identify abnormal trajectories as in mental illness.

Conditions

Healthy Adult Participants; Synaptic Plasticity

Keywords

PET Imaging

Outcome Measures

Primary Outcomes (2)

• Non-invasive quantification of synaptic pruning

  1\. Age-related changes in synaptic density through young adulthood o Cross-sectional age-related (18-26 years of age) changes in synaptic density via SUVR quantified within the dorsolateral prefrontal cortex.

  The PET-CT scan will be within approximately 30 days of the parent study MRI.

• Non-invasive quantification of synaptic pruning

  2\. Within-subject associations of synapse density to MRI-derived measures of brain membrane byproducts o Synaptic density, based on SUVR modeling of \[11C\]UCB-J acquisitions, will be compared to ultra-high field (7 Tesla) \[31P\]MRSI measurement of membrane phospholipid levels obtained from the same participants.

  The PET-CT scan will be within approximately 30 days of the parent study MRI.

Study Arms (1)

PET Imaging Supplemental Component

EXPERIMENTAL

Adult participants enrolled in the parent study, will be given the option to be a part of the PET imaging supplemental project. Maximum enrollment is 60 adult participants. Interested participants will be consented into the PET portion, and will have a single PET scan (as outlined in the Study Description section).

Radiation: PET Imaging Scan using [11C]UCB-J

Interventions

PET Imaging Scan using [11C]UCB-J RADIATION

\[11C\]UCB-J (\~ 15 mCi and ≤ 6μg) will be injected as a slow intravenous bolus. Following an intravenous bolus injection of \[11C\]UCB-J, the participants will be positioned in the scanner for a low dose CT scan (for attenuation correction) fifty-five minutes after the \[11C\]UCB-J injection, and emission data will be collected.

PET Imaging Supplemental Component

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between 18-26 years of age, AND currently enrolled in the Parent Project (R01MH067924)

You may not qualify if:

• Head injury with loss of consciousness over an hour.
• A vision problem or eye movement problem (such as lazy eye, double vision, blurred vision, or color blindness).
• A learning disability and/or ever had an Individualized Education Plan (IEP) in school.
• Significant neurological or metabolic illness: Epilepsy, Meningitis, Encephalitis, Diabetes, Huntington's disease.
• Diagnosed with a psychiatric disorder.
• Participants with, or with a first degree relative, having a DSM IV Axis l psychiatricdisorder.
• Metal implants or ferromagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.) Dental fillings do not present a risk for MRI. If there is a possibility of metal being present in the participant's body, the participant will be excluded from the study.
• Weight more than 250 pounds.
• Claustrophobia or uncomfortable in small spaces.
• \<70% on the Achenbach scale (either from Youth Self Report (YSR) or Adult Self Report (ASR)).
• IQ \< 80 or IQ \> 130.
• Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
• Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study \[studies\] and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of \[C-11\]UCB-J
• History of drug or alcohol abuse (from parent study eligibility).

Sponsors & Collaborators

• Beatriz Luna: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Laboratory of Neurocognitive Development

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one

Study Officials

• Beatriz Luna, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 6, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon completion of the study.
• Access Criteria: Access of shared IPD is managed by the NIH Data Archive.

Locations

US (1)