Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

NCT ID: NCT04726527

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-15
• Study Completion Date: 2017-02-28

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.

Conditions

Primary Progressive Aphasia; Alzheimer Disease; Dementia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Florbetapir F 18

Intervention Type: DRUG

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

Positron Emission Tomography

Intervention Type: DEVICE

PET Scan for brain imaging

Interventions

Florbetapir F 18

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

Intervention Type: DRUG

Positron Emission Tomography

PET Scan for brain imaging

Intervention Type: DEVICE

Other Intervention Names

trade name Amyvid; PET

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Rogalski, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The Healthy Aging & Alzheimer's Research Care Center - University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB23-1391

Identifier Type: -

Identifier Source: org_study_id