Trial Outcomes & Findings for Novel in Vivo Synaptic Imaging in Experienced Meditators (NCT NCT05418608)
NCT ID: NCT05418608
Last Updated: 2026-06-10
Results Overview
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.
COMPLETED
PHASE1
40 participants
Up to 6 months
2026-06-10
Participant Flow
Participant milestones
| Measure |
Meditators
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
Non-meditating Controls
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel in Vivo Synaptic Imaging in Experienced Meditators
Baseline characteristics by cohort
| Measure |
Meditators
n=20 Participants
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
Non-meditating Controls
n=20 Participants
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10.8 • n=9 Participants
|
54.5 years
STANDARD_DEVIATION 8 • n=27 Participants
|
55.7 years
STANDARD_DEVIATION 9.4 • n=267 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
35 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=9 Participants
|
20 participants
n=27 Participants
|
40 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsImaging 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.
Outcome measures
| Measure |
Meditators
n=20 Participants
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
Non-meditating Controls
n=20 Participants
Subjects will undergo one PET scan with \[11C\]UCB-J and one MRI scan for anatomical identification of brain regions.
|
|---|---|---|
|
Binding Potential Using Synaptic Density
cerebral cortex
|
4.75 binding potential
Standard Deviation 0.45
|
5.23 binding potential
Standard Deviation 0.71
|
|
Binding Potential Using Synaptic Density
amygdala
|
3.58 binding potential
Standard Deviation 0.33
|
4.01 binding potential
Standard Deviation 0.49
|
|
Binding Potential Using Synaptic Density
hippocampus
|
2.40 binding potential
Standard Deviation 0.28
|
2.74 binding potential
Standard Deviation 0.49
|
|
Binding Potential Using Synaptic Density
Anterior Cingulate Cortex
|
4.94 binding potential
Standard Deviation 0.58
|
5.46 binding potential
Standard Deviation 0.77
|
|
Binding Potential Using Synaptic Density
Posterior cingulate cortex
|
4.48 binding potential
Standard Deviation 0.40
|
4.82 binding potential
Standard Deviation 0.66
|
|
Binding Potential Using Synaptic Density
Anterior cingulate cortex
|
4.94 binding potential
Standard Deviation 0.58
|
5.46 binding potential
Standard Deviation 0.77
|
|
Binding Potential Using Synaptic Density
Insula
|
4.47 binding potential
Standard Deviation 0.50
|
4.87 binding potential
Standard Deviation 0.68
|
|
Binding Potential Using Synaptic Density
thalamus
|
2.33 binding potential
Standard Deviation 0.23
|
2.60 binding potential
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Up to 3 monthsMeditation 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.
Outcome measures
| Measure |
Meditators
n=20 Participants
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.
Radiotracer: A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
|
Non-meditating Controls
Subjects will undergo one PET scan with \[11C\]UCB-J and one MRI scan for anatomical identification of brain regions.
|
|---|---|---|
|
Evaluating the Correlation Between Data Collected From Meditation Questionnaires and Synaptic Vesicle Glycoprotein 2 (SV2A) Binding
|
-0.44 correlation coefficient
|
—
|
Adverse Events
Meditators
Non-meditating Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place