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

Institute for Neurodegenerative Disorders

Status and phase

Completed

Phase 1

Conditions

Parkinson Disease

Treatments

Drug: [18F]MK-9470

Study type

Interventional

Funder types

Other

Identifiers

NCT01462708

CB1-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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