Establishing 18F-PBR06 PET Imaging as a Viable Pharmacodynamic Endpoint in MSA
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|ClinicalTrials.gov Identifier: NCT03033680|
Recruitment Status : Unknown
Verified January 2017 by Vikram Khurana, Brigham and Women's Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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: Our 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)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Establishing 18F-PBR06 PET Imaging as a Viable Pharmacodynamic Endpoint in MSA|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: Multiple Systems Atrophy (MSA-C)
Four subjects with a probable MSA-C diagnosis will be recruited for this study. To be eligible, the subjects must be between 18 and 60 years of age, have an available brain MRI, and motor symptom onset less than two years prior. Each subject will undergo a [F-18]PBR06 PET scan at baseline, and at 9 months follow-up.
- 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
|Contact: Kelsey O'Connorfirstname.lastname@example.org|
|Principal Investigator:||Vikram Khuana, M.D.||Brigham and Women's Hospital|
|Principal Investigator:||Tarun Singhal, M.D.||Brigham and Women's Hospital|