Brief Summary

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

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.

• Study Type: Interventional
• Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Study Primary Completion Date: May 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Drug: [18F]MK-9470
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Assess [18F]MK-9470 and PET imaging
  • To Assess [18F]MK-9470 and PET imaging

Outcome Measures for this Clinical Trial

Primary Measures

• To determine the functional activity of cannabinoid receptor in advanced Parkinson disease (aPD) and advanced Parkinson disease with dyskinesia (aPD-dys) and compare with early PD (ePD) and healthy control subjects.
  • Time Frame: Approximately 2 years
    Safety Issue?: Yes

Secondary Measures

• To obtain test/retest reproducibility of quantitative PET outcome measures with [18F] -MK-9470
  • Time Frame: Approximately 2 years
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Institute for Neurodegenerative Disorders
• Provider of Information About this Clinical Study
  • Principal Investigator: Danna Jennings, MD, Danna Jennings, MD - Institute for Neurodegenerative Disorders
• Overall Official(s)
  • Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
• Overall Contact(s)
  • Barbara Fussell, RN, 800-401-6067, bfussell@indd.org