Clinical Evaluation of Florbetapir in P… | Clinical Trial

Key information

Conditions

Primary Progressive Aphasia Alzheimer Disease Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

florbetapir F 18

Drug

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

Other names: trade name Amyvid

Positron emission tomography

Device

PET Scan for brain imaging

Other names: PET

Primary outcomes

Detecting amyloid burden in subjects with neurodegenerative diseases

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: PPA

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2017
First posted: Jan 27, 2021
Registry last updated: Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting