Establishing 18F-PBR06 PET Imaging as a Viable Pharmacodynamic Endpoint in MSA
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|ClinicalTrials.gov Identifier: NCT03033680|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : April 26, 2021
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|MSA||Drug: [F-18]PBR06||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Establishing 18F-PBR06 PET Imaging as a Viable Pharmacodynamic Endpoint in MSA|
|Actual Study Start Date :||March 24, 2017|
|Actual Primary Completion Date :||January 15, 2021|
|Actual Study Completion Date :||January 15, 2021|
Experimental: Multiple System Atrophy (MSA)
Eight subjects with a probable MSA diagnosis will be recruited for this study. Each subject will undergo a [F-18]PBR06 PET scan at baseline, and at 9 months follow-up.
Other Name: [18-F]PBR06
- Tissue Volume of Distribution [ Time Frame: 1 month ]PET imaging measurement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033680
|United States, Massachusetts|
|Movement Disorders Clinic, 60 Fenwood Road|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Vikram Khuana, MD, PhD||Brigham and Women's Hospital|