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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01462708
• Date of registration: 08/06/2011
• Prospective Registration: No
• Primary sponsor: Institute for Neurodegenerative Disorders
• Public title: Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects MK9470
• Scientific 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
• Date of first enrolment: May 2011
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01462708
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Danna Jennings, MD
• Affiliation: Institute for Neurodegenerative Disorders

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: [18F]MK-9470

Primary Outcome(s)

Dynamic uptake and washout of [18F]MK-9470 [Time Frame: Approximately 2 years]

Secondary Outcome(s)

To acquire safety data [Time Frame: Approximately 2 years]

Secondary ID(s)

CB1-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors