Clinical Evaluation of Florbetapir in Primary Progressive Aphasia (PPA)

Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline in Primary Progressive Aphasia

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

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Primary Progressive Aphasia
• Intervention / Treatment: Drug: Florbetapir F 18; Device: Positron Emission Tomography

Detailed Description

This study is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The Healthy Aging & Alzheimer's Research Care Center - University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures

Exclusion Criteria:

• Clinically significant cardiovascular disease
• clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
• Pregnant
• Breastfeeding
• Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
• History of relevant severe drug allergy or hypersensitivity
• Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Florbetapir F 18 Recipients; Participants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging.	Drug: Florbetapir F 18; A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.; Other Names: trade name Amyvid; Device: Positron Emission Tomography; PET Scan for brain imaging; Other Names: PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting amyloid burden in subjects with neurodegenerative diseases	The study will provide standardized conditions for florbetapir F 18 use, amyloid binding as measured by PET imaging, and long-term outcome in cognitively normal volunteers, patients with Alzheimer's Disease, patients with Mild Cognitive Impairment, and patients with other neurodegenerative diseases. It will also facilitate evaluation of subject's amyloid burden in companion studies such as longitudinal studies of aging, studies of progressive cognitive impairment, and studies of imaging and blood/cerebrospinal fluid biomarkers of neurodegenerative disease.	4 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Emily Rogalski, Ph.D, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2012
• Primary Completion (Actual): September 2, 2015
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Dementia; Neurocognitive Disorders; Primary Progressive Aphasia; Speech Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Dementia; Alzheimer Disease; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: IRB23-1391

Drug and device information, study documents

• 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