Behavior, HealthPhase 1app311_medNCT05418608

Novel in Vivo Synaptic Imaging in Experienced Meditators

A Phase 1 study testing Radiotracer in people with Behavior, Health, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To utilize positron emission tomography (PET) imaging to characterize the distribution of (aka [11C]APP311at the Yale PET Center) in cortical and subcortical areas in experienced meditators compared to non-meditating controls. Read more about this study

Who is it for?: Ages 28 to 70 years
Conditions the study is for: Behavior, Health
What is being tested?: Radiotracer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 21 Apr 2022to 1 Apr 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 28 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 28-70 years
Voluntary, written, informed consent
Physically healthy by medical history, physical, ECG and laboratory examinations
At least 10 years and 5,000 hours of regular meditation practice
For females, non-lactating, no longer of child-bearing potential or agree to practice effective contraception during the study, as well as a negative serum pregnancy (β-HCG) test at screening, and negative urine pregnancy on PET scanning days.

Who cannot join

A history of significant psychiatric, medical (e.g., cardiovascular, renal) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness that is unstable and/or might affect the study objectives.
Current or history of substance dependence (e.g., alcohol, nicotine, opiates, sedative hypnotics, etc.)
Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.)
History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
Medications that effect SV2A binding (e.g., levetiracetam).

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University PET Center
New Haven, Connecticut, 06519

Other trials in United States

About this study

Read the detailed description

The investigators will conduct a PET study of the novel SV2A imaging tracer [11C]UCB-J in participants, to characterize the distribution of [11C]UCB-J in cortical and subcortical areas in experienced meditators compared to non-meditating controls. A total of up to 20 subjects will complete the study. Subjects will undergo one PET scan with [11C]UCB-J. Each subject will also undergo one MRI scan for anatomical identification of brain regions.

Conditions: Behavior, Health
Being tested: Radiotracer
Keywords: Meditation, Experienced meditators
Medical subject headings: Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RadiotracerDrug
Also called [11C]APP311, [11C]UCB-J
A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.

Study groups in NCT05418608
Study group	Role	What they receive
Meditators	Experimental	A PET study of the novel SV2A imaging tracer [11C]UCB-J in participants, to characterize the distribution of [11C]UCB-J in cortical and subcortical areas in experienced meditators compared to non-meditating controls. Subjects will undergo one PET scan with [11C]UCB-J and one MRI scan for anatomical identification of brain regions. Receives: Drug: Radiotracer
Non-meditating controls	Active comparator	Meditators compared to non-meditating controls. Subjects will undergo one PET scan with [11C]UCB-J and one MRI scan for anatomical identification of brain regions. Receives: Drug: Radiotracer

What is being measured

The primary outcome is the main question the study is designed to answer.

Binding Potential Using Synaptic Density
Imaging data was analyzed using kinetic modeling approaches to quantitate total tracer binding, volume of distribution, and binding potential, specifically voxel-by-voxel compartment model fitting with the arterial input function. Positron emission tomography (PET) images will be registered to the subject's T1-weighted magnetic resonance (MR) images, and then registered to an magnetic resonance template. Gray matter regions of interest are determined by combining a predefined set of regions, defined on the template (FreeSurfer) with the gray matter segmentation mask (FAST algorithm in FSL). This process will permit direct, automatic determination of outcome values. Partial volume correction will also be applied to account for atrophy. Magnetic resonance (MR) image analyses will be done by standardized methods. Values reported for each region represent the binding potential. Binding potential is a unitless measure.
Measured: Up to 6 months

Secondary outcomes (1)

Evaluating the Correlation Between Data Collected From Meditation Questionnaires and Synaptic Vesicle Glycoprotein 2 (SV2A) Binding
Meditation assessments collected from participants, containing mindfulness and attention measures, will be correlated with synaptic vesicle glycoprotein 2 (SV2A) binding data, collected during a positron emission tomography scan in the Anterior Cingulate Cortex. Data presented here is the correlation between Meditation years to SV2A availability.
Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 20221 Apr 2024

First posted14 Jun 2022
Study start21 Apr 2022
Primary completion1 Apr 2024
Study completion1 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Behavior, HealthStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05418608
Sponsor's protocol ID: 2000030601
Other IDs: 1R21AT011575-01
Acronym: app311_med
Status last verified: May 2026
First submitted: 7 Jun 2022
Last updated: 10 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 26848175
Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18.
PubMed 25783612
Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
PubMed 17764203
Marchand WR. Neural mechanisms of mindfulness and meditation: Evidence from neuroimaging studies. World J Radiol. 2014 Jul 28;6(7):471-9. doi: 10.4329/wjr.v6.i7.471.
PubMed 25071887
Ivanovski B, Malhi GS. The psychological and neurophysiological concomitants of mindfulness forms of meditation. Acta Neuropsychiatr. 2007 Apr;19(2):76-91. doi: 10.1111/j.1601-5215.2007.00175.x.
PubMed 26952819
Marchand WR. Mindfulness-based stress reduction, mindfulness-based cognitive therapy, and Zen meditation for depression, anxiety, pain, and psychological distress. J Psychiatr Pract. 2012 Jul;18(4):233-52. doi: 10.1097/01.pra.0000416014.53215.86.
PubMed 22805898
Afonso RF, Kraft I, Aratanha MA, Kozasa EH. Neural correlates of meditation: a review of structural and functional MRI studies. Front Biosci (Schol Ed). 2020 Mar 1;12(1):92-115. doi: 10.2741/S542.
PubMed 32114450
Brewer JA, Worhunsky PD, Gray JR, Tang YY, Weber J, Kober H. Meditation experience is associated with differences in default mode network activity and connectivity. Proc Natl Acad Sci U S A. 2011 Dec 13;108(50):20254-9. doi: 10.1073/pnas.1112029108. Epub 2011 Nov 23.
PubMed 22114193
Raichle ME. The brain's default mode network. Annu Rev Neurosci. 2015 Jul 8;38:433-47. doi: 10.1146/annurev-neuro-071013-014030. Epub 2015 May 4.
PubMed 25938726
Northoff G, Heinzel A, de Greck M, Bermpohl F, Dobrowolny H, Panksepp J. Self-referential processing in our brain--a meta-analysis of imaging studies on the self. Neuroimage. 2006 May 15;31(1):440-57. doi: 10.1016/j.neuroimage.2005.12.002. Epub 2006 Feb 7.
PubMed 16466680
Fox KC, Nijeboer S, Dixon ML, Floman JL, Ellamil M, Rumak SP, Sedlmeier P, Christoff K. Is meditation associated with altered brain structure? A systematic review and meta-analysis of morphometric neuroimaging in meditation practitioners. Neurosci Biobehav Rev. 2014 Jun;43:48-73. doi: 10.1016/j.neubiorev.2014.03.016. Epub 2014 Apr 3.
PubMed 24705269
Van Dam NT, van Vugt MK, Vago DR, Schmalzl L, Saron CD, Olendzki A, Meissner T, Lazar SW, Kerr CE, Gorchov J, Fox KCR, Field BA, Britton WB, Brefczynski-Lewis JA, Meyer DE. Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation. Perspect Psychol Sci. 2018 Jan;13(1):36-61. doi: 10.1177/1745691617709589. Epub 2017 Oct 10.
PubMed 29016274
Weinberger DR, Radulescu E. Structural Magnetic Resonance Imaging All Over Again. JAMA Psychiatry. 2021 Jan 1;78(1):11-12. doi: 10.1001/jamapsychiatry.2020.1941. No abstract available.
PubMed 32697315
Boubela RN, Kalcher K, Huf W, Seidel EM, Derntl B, Pezawas L, Nasel C, Moser E. fMRI measurements of amygdala activation are confounded by stimulus correlated signal fluctuation in nearby veins draining distant brain regions. Sci Rep. 2015 May 21;5:10499. doi: 10.1038/srep10499.
PubMed 25994551
Turner R. How much cortex can a vein drain? Downstream dilution of activation-related cerebral blood oxygenation changes. Neuroimage. 2002 Aug;16(4):1062-7. doi: 10.1006/nimg.2002.1082.
PubMed 12202093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel in Vivo Synaptic Imaging in Experienced Meditators
ClinicalTrials.gov ID: NCT05418608
Acronym / sponsor ID: app311_med / 2000030601
Conditions: Behavior, Health
Keywords: Meditation, Experienced meditators
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 21 Apr 2022 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 1 Apr 2024 (actual)
First posted: 14 Jun 2022 (actual)
Results: Posted 10 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Meditators	Experimental	Drug: RadiotracerA PET study of the novel SV2A imaging tracer [11C]UCB-J in participants, to characterize the distribution of [11C]UCB-J in cortical and subcortical areas in experienced meditators compared to non-meditating controls. Subjects will undergo one PET scan with [11C]UCB-J and one MRI scan for anatomical identification of brain regions.
Non-meditating controls	Active comparator	Drug: RadiotracerMeditators compared to non-meditating controls. Subjects will undergo one PET scan with [11C]UCB-J and one MRI scan for anatomical identification of brain regions.

Who may qualify

Ages: 28 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 28-70 years
Voluntary, written, informed consent
Physically healthy by medical history, physical, ECG and laboratory examinations
At least 10 years and 5,000 hours of regular meditation practice
For females, non-lactating, no longer of child-bearing potential or agree to practice effective contraception during the study, as well as a negative serum pregnancy (β-HCG) test at screening, and negative urine pregnancy on PET scanning days.

Key exclusion criteria (7 listed)

A history of significant psychiatric, medical (e.g., cardiovascular, renal) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness that is unstable and/or might affect the study objectives.
Current or history of substance dependence (e.g., alcohol, nicotine, opiates, sedative hypnotics, etc.)
Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.)

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
RadiotracerAlso: [11C]APP311, [11C]UCB-JA novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.	Drug	Meditators, Non-meditating controls

Primary outcome

Binding Potential Using Synaptic Density
Time frame: Up to 6 months
Imaging data was analyzed using kinetic modeling approaches to quantitate total tracer binding, volume of distribution, and binding potential, specifically voxel-by-voxel compartment model fitting with the arterial input function. Positron emission tomography (PET) images will be registered to the subject's T1-weighted magnetic resonance (MR) images, and then registered to an magnetic resonance template. Gray matter regions of interest are determined by combining a predefined set of regions, defined on the template (FreeSurfer) with the gray matter segmentation mask (FAST algorithm in FSL). This process will permit direct, automatic determination of outcome values. Partial volume correction will also be applied to account for atrophy. Magnetic resonance (MR) image analyses will be done by standardized methods. Values reported for each region represent the binding potential. Binding potential is a unitless measure.

1 secondary outcome

Evaluating the Correlation Between Data Collected From Meditation Questionnaires and Synaptic Vesicle Glycoprotein 2 (SV2A) Binding
Time frame: Up to 3 months

Results and safety

Results posted to the registry on 10 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meditators	20	20
Non-meditating Controls	20	20

Primary outcome: Binding Potential Using Synaptic Density

Time frame: Up to 6 months. Mean (Standard Deviation). Unit: binding potential

Measure	Meditators n = 20	Non-meditating Controls n = 20
cerebral cortex	4.75 (0.45)	5.23 (0.71)
amygdala	3.58 (0.33)	4.01 (0.49)
hippocampus	2.40 (0.28)	2.74 (0.49)
Anterior Cingulate Cortex	4.94 (0.58)	5.46 (0.77)
Posterior cingulate cortex	4.48 (0.40)	4.82 (0.66)
Anterior cingulate cortex	4.94 (0.58)	5.46 (0.77)
Insula	4.47 (0.50)	4.87 (0.68)
thalamus	2.33 (0.23)	2.60 (0.37)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meditators	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Non-meditating Controls	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26848175Nabulsi 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.
Background: PubMed 25783612Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18.
Background: PubMed 17764203Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
Background: PubMed 25071887Marchand WR. Neural mechanisms of mindfulness and meditation: Evidence from neuroimaging studies. World J Radiol. 2014 Jul 28;6(7):471-9. doi: 10.4329/wjr.v6.i7.471.
Background: PubMed 26952819Ivanovski B, Malhi GS. The psychological and neurophysiological concomitants of mindfulness forms of meditation. Acta Neuropsychiatr. 2007 Apr;19(2):76-91. doi: 10.1111/j.1601-5215.2007.00175.x.
Background: PubMed 22805898Marchand WR. Mindfulness-based stress reduction, mindfulness-based cognitive therapy, and Zen meditation for depression, anxiety, pain, and psychological distress. J Psychiatr Pract. 2012 Jul;18(4):233-52. doi: 10.1097/01.pra.0000416014.53215.86.
Background: PubMed 32114450Afonso RF, Kraft I, Aratanha MA, Kozasa EH. Neural correlates of meditation: a review of structural and functional MRI studies. Front Biosci (Schol Ed). 2020 Mar 1;12(1):92-115. doi: 10.2741/S542.
Background: PubMed 22114193Brewer JA, Worhunsky PD, Gray JR, Tang YY, Weber J, Kober H. Meditation experience is associated with differences in default mode network activity and connectivity. Proc Natl Acad Sci U S A. 2011 Dec 13;108(50):20254-9. doi: 10.1073/pnas.1112029108. Epub 2011 Nov 23.
Background: PubMed 25938726Raichle ME. The brain's default mode network. Annu Rev Neurosci. 2015 Jul 8;38:433-47. doi: 10.1146/annurev-neuro-071013-014030. Epub 2015 May 4.
Background: PubMed 16466680Northoff G, Heinzel A, de Greck M, Bermpohl F, Dobrowolny H, Panksepp J. Self-referential processing in our brain--a meta-analysis of imaging studies on the self. Neuroimage. 2006 May 15;31(1):440-57. doi: 10.1016/j.neuroimage.2005.12.002. Epub 2006 Feb 7.
Background: PubMed 24705269Fox KC, Nijeboer S, Dixon ML, Floman JL, Ellamil M, Rumak SP, Sedlmeier P, Christoff K. Is meditation associated with altered brain structure? A systematic review and meta-analysis of morphometric neuroimaging in meditation practitioners. Neurosci Biobehav Rev. 2014 Jun;43:48-73. doi: 10.1016/j.neubiorev.2014.03.016. Epub 2014 Apr 3.
Background: PubMed 29016274Van Dam NT, van Vugt MK, Vago DR, Schmalzl L, Saron CD, Olendzki A, Meissner T, Lazar SW, Kerr CE, Gorchov J, Fox KCR, Field BA, Britton WB, Brefczynski-Lewis JA, Meyer DE. Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation. Perspect Psychol Sci. 2018 Jan;13(1):36-61. doi: 10.1177/1745691617709589. Epub 2017 Oct 10.
Individual participant dataSharing planned: Yes

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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. This study is not recruiting at the moment.

David Matuskey, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radiotracer in people with Behavior, Health, run by Yale University 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jun 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Binding Potential Using Synaptic Density (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418608, which also lists 22 linked publications.

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 10 Jun 2026; AzTrials last refreshed its copy on 5 Nov 2026.