Florbetaben PET Imaging in PPA

NCT04720001 | Completed FDA Drug

• 1 other identifier: IRB23-1360
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Progressive Aphasia; Alzheimer Disease

Keywords

Alzheimer's Disease; Dementia; Primary Progressive Aphasia; Neurocognitive Disorders; Speech Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Device: PET

Interventions

Florbetaben F18 DRUG

A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection

Also known as: trade name NeuraCeq

Experimental: Florbetaben F18 recipients

PET DEVICE

PET Scan for brain imaging

Experimental: Florbetaben F18 recipients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant
• Breastfeeding
• Receiving radiation clinically

Sponsors & Collaborators

• University of Chicago: lead
• Northwestern University: collaborator

Study Sites (1)

University of Chicago - American School Building

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Alzheimer Disease; Dementia; Neurocognitive Disorders; Speech Disorders

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Emily Rogalski, Ph.D

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: August 23, 2018
• Primary Completion: January 21, 2021
• Study Completion: February 26, 2021
• Last Updated: October 16, 2024

Record last verified: 2022-02

Locations

US (1)