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

NCT03033680 | Completed Phase 1 FDA Drug

• 1 other identifier: 2016P002373
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

MSA

Outcome Measures

Primary Outcomes (1)

• Tissue Volume of Distribution

  PET imaging measurement

  1 month

Study Arms (1)

Multiple System Atrophy (MSA)

EXPERIMENTAL

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

Interventions

[F-18]PBR06 DRUG

PET radiopharmaceutical

Also known as: [18-F]PBR06

Multiple System Atrophy (MSA)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Probable MSA clinical diagnosis.
• Male and female subjects age 18 to 70 years.
• Motor symptom onset \<2 years prior.
• Available brain MRI.

You may not qualify if:

• Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
• Individuals with bipolar disease and schizophrenia
• Concurrent medical conditions that contraindicate study procedures.
• 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.
• Claustrophobia
• Corticosteroid treatment in the past four weeks
• Non-MRI compatible implanted devices
• Low Affinity binders

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Movement Disorders Clinic, 60 Fenwood Road

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Vikram Khuana, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 27, 2017
• Study Start: March 24, 2017
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

US (1)