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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT01462708
First received: June 8, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Parkinson Disease
Drug: [18F]MK-9470
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Dynamic uptake and washout of [18F]MK-9470 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
    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:
  • To acquire safety data [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
    Safety will be assessed by the number of adverse events experienced by subjects and any clinically significant changes in laboratory tests or vital signs.


Enrollment: 16
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • [18F]MK-9470
  • Parkinson Disease
  • Cannabinoid-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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT01462708     History of Changes
Other Study ID Numbers: CB1-01
Study First Received: June 8, 2011
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014