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

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID: NCT01462708
Run by: Institute for Neurodegenerative Disorders
People needed: 16
Starts: 2011-05-01
Expected to finish: 2013-05-01
Last updated by the study team: 2013-11-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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