Florbetaben PET Imaging in PPA

October 14, 2024 updated by: University of Chicago

Florbetaben PET Imaging in Primary Progressive Aphasia

The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago - American School Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States. As Primary Progressive Aphasia is an uncommon syndrome, participant recruitment is not focused on a specific demographic area.

Description

Inclusion Criteria:

  • Participants must have a diagnosis of PPA or a related dementia syndrome

Exclusion Criteria:

  • Pregnant
  • Breastfeeding
  • Receiving radiation clinically

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Florbetaben F18 recipients
Participants in this arm of the study will receive 8.1mCi of florbetaben F18 and then be scanned in a PET scanner for brain imaging.
Drug: Florbetaben F18
A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection
Other Names:
  • trade name NeuraCeq
Device: PET
PET Scan for brain imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amyloid plaque levels in PPA participants
Time Frame: 2 Years
Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Emily Rogalski, Ph.D, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

February 26, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-1360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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