Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

University of Chicago48 enrolled

Overview

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

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

Conditions

Primary Progressive Aphasia Alzheimer Disease Dementia

Interventions

Florbetapir F 18DRUG

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

Positron Emission TomographyDEVICE

PET Scan for brain imaging

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 years

Data from ClinicalTrials.gov

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