Status:
COMPLETED
Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a
Lead Sponsor:
Institute for Neurodegenerative Disorders
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The underlying goal of this study is to assess \[18F\]MPPF PET imaging as a tool to evaluate the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research participants.
Detailed Description
Approximately 40 subjects with Parkinson disease and 20 healthy control subjects will be recruited to participate in the 2 Projects in this study. All subjects will undergo written informed consent an...
Eligibility Criteria
Inclusion
- PD Subjects
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria).
- Modified Hoehn and Yahr stage of 1 - 4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\] CFPyPB injection.
Exclusion
- The subject has a clinically significant 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 subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, 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
- Subject treated with medication known to interfere with \[18F\]MPPF binding in vivo (e.g. pindolol)
- Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation \>15 mSv over the past 12 months.
- 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 \[18F\]MPPF 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.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subject treated with medication known to interfere with \[18F\]MPPF binding in vivo (e.g. pindolol)
- Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation \>15 mSv over the past 12 months.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01461083
Start Date
September 1 2011
End Date
May 1 2014
Last Update
June 4 2014
Active Locations (1)
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1
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510