Establishing 18F-PBR06 PET Imaging as a Viable Pharmacodynamic Endpoint in MSA

• Status: Completed
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The specific aims of the study are:

Primary: To determine the presence and regional distribution of microglial activation, as assessed by [F-18]PBR06 PET, in subjects with MSA as compared to healthy controls, at baseline and at 9 months follow-up.

Secondary:

To assess the relationship between microglial activation and clinical progression at baseline and follow-up.

Hypothesis: The working hypothesis is that there is microglial activation in Multiple System Atrophy and that the presence and regional distribution of microglial activation is different in MSA versus healthy controls and correlates with disease severity and comorbidities.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

Criteria

Inclusion Criteria:

1. Probable MSA clinical diagnosis.

2. Male and female subjects age 18 to 70 years.

3. Motor symptom onset <2 years prior.

4. Available brain MRI.

Exclusion Criteria:

1. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.

2. Individuals with bipolar disease and schizophrenia

3. Concurrent medical conditions that contraindicate study procedures.

4. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.

5. Claustrophobia

6. Corticosteroid treatment in the past four weeks

7. Non-MRI compatible implanted devices

8. Low Affinity binders