Clinical trial NCT01462708: Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Molecular NeuroImaging
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
First posted: 2011-10-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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: 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

Primary outcomes:
measure: Dynamic uptake and washout of [18F]MK-9470
timeFrame: Approximately 2 years
Secondary outcomes:
measure: To acquire safety data
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: