Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT01461083

Run by

Institute for Neurodegenerative Disorders

People needed

19

Starts

2011-09-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Molecular NeuroImaging, LLC — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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