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

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ClinicalTrials.gov Identifier: NCT01462708
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: [18F]MK-9470 Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : May 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Dynamic uptake and washout of [18F]MK-9470 [ Time Frame: 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 :
  1. To acquire safety data [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462708


Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
More Information

Additional Information:
Responsible Party: Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT01462708     History of Changes
Other Study ID Numbers: CB1-01
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Keywords provided by Danna Jennings, MD, Institute for Neurodegenerative Disorders:
Parkinson Disease
Molecular NeuroImaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases