Parkinson Disease
Conditions
Keywords
Parkinson Disease, Molecular NeuroImaging
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.
Interventions
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.
Sponsors
Institute for Neurodegenerative Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic uptake and washout of [18F]MK-9470 | 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
| Measure | Time frame | Description |
|---|---|---|
| To acquire safety data | 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. |
Countries
United States
Outcome results
None listed