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Completed

NCT Number: NCT05418608

Novel in Vivo Synaptic Imaging in Experienced Meditators

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.

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Key information

Age range

28 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University PET Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Radiotracer

Drug

A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.

Other names: [11C]APP311, [11C]UCB-J

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluating the Correlation Between Data Collected From Meditation Questionnaires and Synaptic Vesicle Glycoprotein 2 (SV2A) Binding

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: app311_med

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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