Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: [18F]MK-9470

• Registration Number: NCT01462708
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief Summary

The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as a tool to evaluate the activity of the CB-1 receptor in the brain.

Detailed Description

The underlying goal of this study is to assess MK-9470 PET imaging as a tool to evaluate the activity of the CB-1 receptor in the brain of Parkinson's Disease (PD) research participants.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-31
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess [18F]MK-9470 and PET imaging	[18F]MK-9470	To Assess \[18F\]MK-9470 and PET imaging

Primary Outcome Measures

Name	Time	Method
Dynamic uptake and washout of [18F]MK-9470	Approximately 2 years	To assess the dynamic uptake and washout of \[18F\]-MK-9470 in brain using positron emission tomography (PET) in early Parkinson disease and advanced Parkinson disease with and without dyskinesia and similarly aged healthy control subjects as a potential imaging biomarker of the cannabionoid-1 (CB-1) receptor in brain.

Secondary Outcome Measures

Name	Time	Method
To acquire safety data	Approximately 2 years	Safety will be assessed by the number of adverse events experienced by subjects and any clinically significant changes in laboratory tests or vital signs.

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States