Florbetaben PET Imaging in PPA

Alzheimer Disease Clinical Trial

Official title:

Florbetaben PET Imaging in Primary Progressive Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720001
• Other study ID #: STU00206530
• Status: Completed
• Start date: August 23, 2018
• Est. completion date: February 26, 2021

Study information

• Verified date: February 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 26, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

• Breastfeeding

• Receiving radiation clinically

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Drug:
• Florbetaben F18
A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection

Device:
• PET
PET Scan for brain imaging

Locations

Country	Name	City	State
United States	Cognitive Neurology and Alzheimer's Disease Center - Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyloid plaque levels in PPA participants	Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest.	2 Years