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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01462708
Date of registration: 08/06/2011
Prospective Registration: Yes
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
Address: 
Telephone:
Email:
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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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