Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

Completed

• Conditions: Alzheimer Disease; Primary Progressive Aphasia; Dementia
• Interventions: Drug: Florbetapir F 18; Device: Positron Emission Tomography

• Registration Number: NCT04726527
• Lead Sponsor: Northwestern University

Brief Summary

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

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 Timeline

• Study Start: 2012-03-15
• Primary Completion: 2015-09-02
• Study Completion: 2017-02-28
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Florbetapir F 18 Recipients	Positron Emission Tomography	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.
Florbetapir F 18 Recipients	Florbetapir F 18	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.

Primary Outcome Measures

Name	Time	Method
Detecting amyloid burden in subjects with neurodegenerative diseases	4 years	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.

Trial Locations

Locations (1)

The Healthy Aging & Alzheimer's Research Care Center - University of Chicago; 🇺🇸 Chicago, Illinois, United States