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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders
• Treatments: Serotonin

Criteria

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).

• 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 Criteria:

• 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.