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Synaptic Imaging for Health Behaviors (app311_med Trial)

Phase 1

Recruiting

Led By David Matuskey, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 28-70 years

Physically healthy by medical history, physical, ECG and laboratory examinations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

app311_med Trial Summary

This trial will use PET imaging to compare how a certain molecule is distributed in the brains of experienced meditators versus non-meditating controls.

Who is the study for?

This trial is for healthy adults aged 28-70 who have practiced meditation regularly for at least 10 years and accumulated over 5,000 hours. They must be non-lactating, not pregnant, and willing to use contraception if of child-bearing potential. People with substance dependence, bleeding disorders, certain medication use or excessive prior radiation exposure cannot participate.Check my eligibility

What is being tested?

The study uses PET imaging to compare brain activity related to synaptic density in experienced meditators versus non-meditators using a radiotracer called [11C]APP311. The goal is to observe differences in cortical and subcortical areas between the two groups.See study design

What are the potential side effects?

Potential side effects from the radiotracer used in PET scans may include allergic reactions or discomfort at the injection site. Long-term risks are minimal but can include increased lifetime risk of cancer due to radiation exposure.

app311_med Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 28 and 70 years old.

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I am physically healthy based on recent medical exams.

app311_med Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analyzing positron emission tomography images in conjunction with magnetic resonance data

Secondary outcome measures

Evaluating the correlation between data collected from meditation questionnaires and synaptic vesicle glycoprotein 2 (SV2A) binding

app311_med Trial Design

1Treatment groups

Experimental Treatment

Group I: Aim 1Experimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,421 Total Patients Enrolled

1 Trials studying Health Behaviors

363 Patients Enrolled for Health Behaviors

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,953 Total Patients Enrolled

3 Trials studying Health Behaviors

2,043 Patients Enrolled for Health Behaviors

David Matuskey, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Radiotracer Clinical Trial Eligibility Overview. Trial Name: NCT05418608 — Phase 1

Health Behaviors Research Study Groups: Aim 1

Health Behaviors Clinical Trial 2023: Radiotracer Highlights & Side Effects. Trial Name: NCT05418608 — Phase 1

Radiotracer 2023 Treatment Timeline for Medical Study. Trial Name: NCT05418608 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept those aged over 25?

"This trial has set 28 years old as the baseline requirement for enrollment, with an upper limit of 70."

Answered by AI

Is it possible to join the clinical research program?

"This clinical trial aims to recruit 20 volunteers with a strong history of health-conscious behavior, aged between 28 and 70. Additionally, applicants must grant voluntary written consent; be physically fit as confirmed by medical assessment, ECG testing and laboratory examinations; have completed at least 10 years/5,000 hours of meditation practice; females are ineligible if they are breastfeeding or may become pregnant through the duration of the study (and therefore need to practice effective contraception measures) - in addition to negative serum pregnancy (β-HCG) test results during screening and negative urine pregnancy tests on PET scanning days."

Answered by AI

Is there a risk of adverse effects from Radiotracer usage?

"There is a dearth of data regarding the safety and efficacy of Radiotracer, so it was given a score of 1."

Answered by AI

How many individuals are participating in this research study?

"Affirmative. Per clinicaltrials.gov, the trial was initially posted on April 21st 2022 and has been actively seeking 20 participants at 1 site since its last edit of June 13th 2022."

Answered by AI

Are there any available slots for enrolment in this trial?

"As per the details available on clinicaltrials.gov, this research is still in search of participants. It was initially posted to the web portal on April 21st 2022 and most recently modified on June 13th 2022."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Meditation Experience Is Associated with Differences in Default Mode Network Activity and Connectivity

Brewer, Judson A., Patrick D. Worhunsky, Jeremy R. Gray, Yi-Yuan Tang, Jochen Weber, and Hedy Kober. 2011. “Meditation Experience Is Associated with Differences in Default Mode Network Activity and Connectivity”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1112029108.

Nature Reviews NeuroscienceJournal

The Neuroscience of Mindfulness Meditation

Tang, Yi-Yuan, Britta K. Hölzel, and Michael I. Posner. 2015. “The Neuroscience of Mindfulness Meditation”. Nature Reviews Neuroscience. Springer Science and Business Media LLC. doi:10.1038/nrn3916.

Annual Review of NeuroscienceJournal

The Brain's Default Mode Network

Raichle, Marcus E.. 2015. “The Brain's Default Mode Network”. Annual Review of Neuroscience. Annual Reviews. doi:10.1146/annurev-neuro-071013-014030.

NeuroImageJournal