NCT05009199

Occupancy of Adenosine A2A Receptors Using the PET Radiotracer [18F]MNI-444

A Phase 1 Proof of Principle Study to Evaluate the Occupancy of A2A Receptors Using PET Radiotracer [18F]MNI-444 & Repeated Dosing of Oral Caffeine in Participants Without Parkinson's Disease Who Carry Pathogenic Mutation in the LRRK2 Gene

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD.

Detailed description

The overall goal of this protocol is to evaluate the binding of caffeine to adenosine A2A receptors in the brain of participants at risk for developing PD. The specific objectives are: * To evaluate the pharmacokinetics (PK) and pharmacodynamics of multiple doses of oral caffeine on striatal binding of the adenosine A2A receptor ligand \[18F\]MNI-444. * To evaluate the safety and tolerability of 3 doses of the positron emission tomography (PET) radiotracer, \[18F\]MNI-444. * To evaluate the safety and tolerability of multiple doses of oral caffeine in this paradigm.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	[18F]MNI-444	Subjects will undergo PET imaging using \[18F\]MNI-444.

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2021-08-17
• Last updated: 2022-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study