Florbetaben PET Imaging in PPA

Completed

• Conditions: Alzheimer Disease; Primary Progressive Aphasia
• Interventions: Drug: Florbetaben F18; Device: PET

• Registration Number: NCT04720001
• Lead Sponsor: University of Chicago

Brief Summary

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

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 Timeline

• Study Start: 2018-08-23
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Primary Completion: 2021-01-21
• Study First Posted: 2021-01-22
• Study Completion: 2021-02-26
• Status Verified: 2022-02
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

• Pregnant
• Breastfeeding
• Receiving radiation clinically

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Florbetaben F18 recipients	Florbetaben F18	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.
Experimental: Florbetaben F18 recipients	PET	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.

Primary Outcome Measures

Name	Time	Method
Amyloid plaque levels in PPA participants	2 Years	Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest.

Trial Locations

Locations (1)

University of Chicago - American School Building; 🇺🇸 Chicago, Illinois, United States