Florbetaben PET Imaging in PPA

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04720001
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Actual Duration (Months): 30.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Aphasia; Alzheimer Disease	Drug: Florbetaben F18; Device: PET

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 Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Florbetaben PET Imaging in Primary Progressive Aphasia
• Actual Study Start Date: Aug 23, 2018
• Actual Primary Completion Date: Jan 21, 2021
• Actual Study Completion Date: Feb 26, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

• Breastfeeding

• Receiving radiation clinically

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cognitive Neurology and Alzheimer's Disease Center - Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Emily Rogalski, Ph.D, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emily Rogalski, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT04720001
• Other Study ID Numbers: STU00206530
• First Posted: Jan 22, 2021
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• 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
• Keywords provided by Emily Rogalski, Principal Investigator, Northwestern University: Alzheimer's Disease; Dementia; Primary Progressive Aphasia; Neurocognitive Disorders; Speech Disorders
• Additional relevant MeSH terms: Alzheimer Disease; Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia

Study Results

No Results Posted as of Feb 22, 2022