Status:
COMPLETED
Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects
Lead Sponsor:
Institute for Neurodegenerative Disorders
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
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.
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 Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01462708
Start Date
May 1 2011
End Date
May 1 2013
Last Update
November 11 2013
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510