Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

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

Detailed Description
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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.

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

Conditions
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Primary Progressive Aphasia, Alzheimer Disease, Dementia

Intervention / Treatment
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* Drug: Florbetapir F 18
* Device: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Florbetapir F 18 Recipients<br>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. | Drug: Florbetapir F 18<br>* A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.<br>* Other names: trade name Amyvid;Device: Positron Emission Tomography<br>* PET Scan for brain imaging<br>* Other names: PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Dementia, Primary Progressive Aphasia, Neurocognitive Disorders, Speech Disorders