Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects (MK9470)

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 Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: [18F]MK-9470

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assess [18F]MK-9470 and PET imaging; To Assess [18F]MK-9470 and PET imaging	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.; Other Names: Parkinson Disease; Cannabinoid-1

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute for Neurodegenerative Disorders

Publications and helpful links

Helpful Links

• Institute for Neurodegenerative Disorders

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 31, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Parkinson Disease; Molecular NeuroImaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CB1-01