Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

Alzheimer Disease Clinical Trial

— PPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726527
• Other study ID #: STU00044931
• Status: Completed
• Start date: March 15, 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: February 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 28, 2017
• Est. primary completion date: September 2, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Drug:
• Florbetapir F 18
A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.

Device:
• Positron Emission Tomography
PET Scan for brain imaging

Locations

Country	Name	City	State
United States	Cognitive Neurology and Alzheimer's Disease Center - Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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