Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Robert Fox

Status and phase: Withdrawn; Early Phase 1

Conditions: Healthy

Treatments: Drug: [11C]MeDAS

Study type: Interventional

Funder types: Other

Identifiers

NCT04333290

MeDAS-001

Details and patient eligibility

About

This study evaluates the safety of [11C]MeDAS, a PET radiotracer.

Full description

Myelin PET imaging provides a new type of information regarding the integrity of the central nervous system based on molecular imaging of myelin. Preclinical studies have shown [11C] MeDAS uptake in the brain and spinal cord to be an indicator of the microstructural integrity of the tissue.

[11C]MeDAS PET (Positron Emission Tomography) scans will be performed on healthy subjects at 2 timepoints to assess for safety of the radiotracer and to assess its performance in humans. Following measurement of [11C]MeDAS pharmacokinetics and biodistribution, an optimal protocol for dosing and imaging will be established.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject reports no known physical diseases of the central nervous system including no history of mental health disorders.
• Capable of giving informed consent
• Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.

Exclusion criteria

• Age <18 or >65
• History of malignant hypertension or hypertensive crisis
• Known infectious disease requiring treatment during the course of the study
• Subject reported history of substance abuse
• inability to undergo an MRI or PET scan

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Arm: Healthy subjects

Experimental group

Description:

The PET radiotracer Myeliviz (\[11C\]MeDAS) will be administered to healthy subjects twice and PET scans will be obtained each time. This will allow assessment of the PET image quality, PET scan reproducibility and radiotracer distribution.

Treatment:

Drug: [11C]MeDAS