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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
Sponsor:
Information provided by (Responsible Party):
Vikram Khurana, Brigham and Women's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
MSA Drug: [F-18]PBR06 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.
Drug: [F-18]PBR06
PET radiopharmaceutical
Other Name: [18-F]PBR06




Primary Outcome Measures :
  1. Tissue Volume of Distribution [ Time Frame: 1 month ]
    PET imaging measurement



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Movement Disorders Clinic, 60 Fenwood Road
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Vikram Khuana, MD, PhD Brigham and Women's Hospital
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Responsible Party: Vikram Khurana, Assistant Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03033680    
Other Study ID Numbers: 2016P002373
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No