Novel in Vivo Synaptic Imaging in Experienced Meditators

NCT05418608 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 20000306011R21AT011575-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Behavior, Health

Keywords

Meditation; Experienced meditators

Outcome Measures

Primary Outcomes (1)

• Analyzing positron emission tomography images in conjunction with magnetic resonance data

  Imaging data will be analyzed by using kinetic modeling approaches; these are used 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 (Anatomical Automatic Labeling (AAL) for SPM2) 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.

  Up to two years

Secondary Outcomes (1)

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

  Up to two years

Study Arms (1)

Aim 1

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.

Drug: Radiotracer

Interventions

Radiotracer DRUG

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

Also known as: [11C]APP311, [11C]UCB-J

Aim 1

Eligibility Criteria

• Age: 28 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Yale University PET Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Health Behavior

Interventions

1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David Matuskey, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: April 21, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)