NCT01461083

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

Phase I Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a in Subjects With Parkinson Disease and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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 and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects in Project 1 (20 PD and 20 HC subjects) will be asked to undergo a single bolus injection of \[18F\]MPPF followed by serial Positron Emission Tomography (PET) imaging scans and blood sampling for measurement of \[18F\]MPPF in plasma (both protein bound and free) over a period of up to 2 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, \[18F\]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects. Subjects participating in Project 2 (20 PD subjects on dopaminergic replacement therapy) will also undergo a second \[18F\]MPPF and PET imaging session, identical except that PD medications will be withheld for approximately 8 hours prior to the imaging session. The second session will occur greater than 7 days, but not more than 3 months, from the first imaging session. Initial 'on' medication quantitative outcomes for each brain region will be compared to the outcomes from the second 'off' medication imaging session to determine the influence of dopaminergic treatment on 5HT1A activity. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, \[18F\]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	[18F]MPPF	Subjects will be dosed by intravenous bolus injection of \[18F\]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not \>10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-11-01
• Completion: 2014-05-01
• First posted: 2011-10-27
• Last updated: 2014-06-04

Locations

1 site across 1 country: United States