Healthy Adult ParticipantsSPA PETNCT07569718
Effects of Adolescent Synaptic Pruning
A study testing PET Imaging Scan using [11C]UCB-J in people with Healthy Adult Participants and Synaptic Plasticity, run by Beatriz Luna at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Synaptic Plasticity
- What is being tested?
- PET Imaging Scan using [11C]UCB-J
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females between 18-26 years of age, AND currently enrolled in the Parent Project (R01MH067924)
- Exclusion Criteria: (these exclusion criteria are outlined in the Parent Project)
- 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.
Show all 16Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Laboratory of Neurocognitive Development
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
The loss of brain cell (neuron) connections (synapses) through human development, known as synaptic pruning, has been characterized in postmortem studies but how this proceeds in live humans as they age into adulthood is not well understood. This study will use the PET tracer [11C]UCB-J which provides a direct measure of synaptic density, in conjunction with previously acquired ultra-high field MRI, in a group of young adults in order to understand how standard MRI-based measures reflect changes in the density of synapses. PET [11C]UCB-J is known to measure the density of synaptic connections by measuring a protein (SV2A) present in synapses. A comparison of results from the current study with MRI-based measures of byproducts of synaptic membrane breakdown from childhood to early adulthood will allow assessment of how non-invasive MRI reflects synaptic pruning through development, facilitating studies of how the brain changes through adolescence and into adulthood, which is needed to identify patterns of development associated with the emergence of mental illness.
- Conditions
- Healthy Adult Participants, Synaptic Plasticity
- Being tested
- PET Imaging Scan using [11C]UCB-J
- Keywords
- PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Imaging Scan using [11C]UCB-JRadiation
[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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: PET Imaging Scan using [11C]UCB-J |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive quantification of synaptic pruning
- Age-related changes in synaptic density through young adulthood
- Cross-sectional age-related (18-26 years of age) changes in synaptic density via SUVR quantified within the dorsolateral prefrontal cortex.
Measured: The PET-CT scan will be within approximately 30 days of the parent study MRI.
Non-invasive quantification of synaptic pruning
- Within-subject associations of synapse density to MRI-derived measures of brain membrane byproducts
- 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.
Measured: The PET-CT scan will be within approximately 30 days of the parent study MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start9 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beatriz Luna
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Beatriz Luna, University of Pittsburgh
- Investigators
- Beatriz Luna, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569718
- Sponsor's protocol ID
- STUDY24060023
- Other IDs
- 3R01MH067924-19S1
- Acronym
- SPA PET
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual \[11C\]UCB-J SUVR maps will be shared via the NIH Data Archive (NDA), along with basic corresponding demographic data (age, sex).
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adolescent Synaptic Pruning
- ClinicalTrials.gov ID
- NCT07569718
- Acronym / sponsor ID
- SPA PET / STUDY24060023
- Conditions
- Healthy Adult Participants, Synaptic Plasticity
- Keywords
- PET Imaging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beatriz LunaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The loss of brain cell (neuron) connections (synapses) through human development, known as synaptic pruning, has been characterized in postmortem studies but how this proceeds in live humans as they age into adulthood is not well understood. This study will use the PET tracer [11C]UCB-J which provides a direct measure of synaptic density, in conjunction with previously acquired ultra-high field MRI, in a group of young adults in order to understand how standard MRI-based measures reflect changes in the density of synapses. PET [11C]UCB-J is known to measure the density of synaptic connections by measuring a protein (SV2A) present in synapses. A comparison of results from the current study with MRI-based measures of byproducts of synaptic membrane breakdown from childhood to early adulthood will allow assessment of how non-invasive MRI reflects synaptic pruning through development, facilitating studies of how the brain changes through adolescence and into adulthood, which is needed to identify patterns of development associated with the emergence of mental illness.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET Imaging Supplemental Component | Experimental | Radiation: PET Imaging Scan using [11C]UCB-JAdult 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females between 18-26 years of age, AND currently enrolled in the Parent Project (R01MH067924)
- Exclusion Criteria: (these exclusion criteria are outlined in the Parent Project)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET Imaging Scan using [11C]UCB-J[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. | Radiation | PET Imaging Supplemental Component |
Primary outcome
Non-invasive quantification of synaptic pruning
Time frame: The PET-CT scan will be within approximately 30 days of the parent study MRI.
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.
Non-invasive quantification of synaptic pruning
Time frame: The PET-CT scan will be within approximately 30 days of the parent study MRI.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Individual [11C]UCB-J SUVR maps will be shared via the NIH Data Archive (NDA), along with basic corresponding demographic data (age, sex).
Related trials for Healthy Adult Participants
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Active, not recruitingPhase 1
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Healthy Volunteers, Hyperuricemia
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
Enrolling by invitationEarly Phase 1
Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study
Healthy Adult Participants
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatriz Luna, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Imaging Scan using [11C]UCB-J in people with Healthy Adult Participants and Synaptic Plasticity, run by Beatriz Luna at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive quantification of synaptic pruning (time frame: The PET-CT scan will be within approximately 30 days of the parent study MRI.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.