Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects (MK9470)
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|ClinicalTrials.gov Identifier: NCT01462708|
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : November 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: [18F]MK-9470||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Assess [18F]MK-9470 and PET imaging
To Assess [18F]MK-9470 and PET imaging
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.
- Dynamic uptake and washout of [18F]MK-9470 [ Time Frame: 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.
- To acquire safety data [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462708
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna Jennings, MD||Institute for Neurodegenerative Disorders|