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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of [18F] MK-9470 and PET as a Marker of Cannabinoid-1 Receptor Activity in Subjects With Parkinson Disease Compared With Healthy Controls

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: [18F]MK-9470


Participation Criteria
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Eligibility Criteria
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Early PD Subjects Inclusion criteria: The participant is 30 years or older. Written informed consent is obtained. Participants have a diagnosis of PD (based on UK Brain Bank Criteria) within the past 2 years. Modified Hoehn and Yahr stages 1-2. No evidence of dyskinesia by history or clinical examination For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection. Advanced PD subjects Inclusion criteria: The participant is 30 years or older. Written informed consent is obtained. Participants have a diagnosis of PD (based on UK Brain Bank Criteria) of at least 5 years duration. Modified Hoehn and Yahr stages 1-4. No evidence of dyskinesia by history or clinical examination For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection. Subjects who have a clinical diagnosis of advanced PD with dyskinesia will be recruited for this study. ePD subjects Inclusion criteria: The participant is 30 years or older. Written informed consent is obtained. Participants have a diagnosis of PD (based on UK Brain Bank Criteria) of at least 5 years. Modified Hoehn and Yahr stages 1-4. Evidence of dyskinesia either by history or clinical examination For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection. PD (all stages- e-PD, aPD, aPD-dys)Subject Selection. Subjects who have a clinical diagnosis of ePD, aPD, aPD-dys will be recruited for this study. All PD subjects Exclusion criteria: The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion. The patient has evidence of unstable gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, pulmonary, or other disorder or disease. Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure Subjects with radiation exposure above acceptable levels Pregnancy Healthy Control Subject Selection: subjects who have no neurological disease will be recruited for this study. Healthy control subjects Inclusion criteria: The participant is 18 years or older. Written informed consent is obtained. Negative history of neurological or psychiatric illness based on evaluation by a research physician. For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]-MK9470 injection. Exclusion criteria: The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness. The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease. The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion. Subjects with radiation exposure above acceptable levels Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assess [18F]MK-9470 and PET imaging<br>To Assess [18F]MK-9470 and PET imaging | Drug: [18F]MK-9470<br>* Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not >10% of 10 mCi limit)of [18F]MK-9470, followed by PET imaging.<br>* Other names: Cannabinoid-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic uptake and washout of [18F]MK-9470 | 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. | Approximately 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Molecular NeuroImaging