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Florbetaben PET Imaging in PPA

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ClinicalTrials.gov Identifier: NCT04720001
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Emily Rogalski, Northwestern University

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Florbetaben PET Imaging in Primary Progressive Aphasia
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : August 23, 2022
Estimated Study Completion Date : August 23, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: trade name NeuraCeq

Device: PET
PET Scan for brain imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Breastfeeding
  • Receiving radiation clinically
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720001


Contacts
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Contact: Christina Coventry, MS, RN 312-908-9681 christina.coventry@northwestern.edu
Contact: Emily Rogalski, Ph.D 312-503-1155 erogalski@northwestern.edu

Locations
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United States, Illinois
Cognitive Neurology and Alzheimer's Disease Center - Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Christina Coventry, MS, RN    312-908-9681    christina.coventry@northwestern.edu   
Contact: Emily Rogalski, Ph.D    312-503-1155    e-rogalski@northwestern.edu   
Principal Investigator: Emily Rogalski, Ph.D         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Emily Rogalski, Ph.D Northwestern University
More Information
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Responsible Party: Emily Rogalski, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04720001    
Other Study ID Numbers: STU00206530
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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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, Northwestern University:
Alzheimer's Disease
Dementia
Primary Progressive Aphasia
Neurocognitive Disorders
Speech Disorders
Additional relevant MeSH terms:
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Alzheimer Disease
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases