Clinical Evaluation of Flortaucipir F 18

Study Overview
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Brief Summary
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This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

Official Title
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Clinical Evaluation of 18F-AV-1451

Conditions
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Alzheimer's Disease, Traumatic Brain Injury, Depression

Intervention / Treatment
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* Drug: Flortaucipir F18
* Procedure: Brain PET scan


Participation Criteria
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Eligibility Criteria
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Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below. Inclusion Criteria: Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study Exclusion Criteria: Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception Have a history of relevant severe drug allergy or hypersensitivity Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study Are patients with current clinically significant unstable medical comorbidities Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flortaucipir PET Scans<br> | Drug: Flortaucipir F18<br>* IV injection, 370 MBq (10 mCi), up to two doses<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Related to Flortaucipir Administration | Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in Adverse Events section below). | within 48 hours of drug administration | 
| Flortaucipir PET Scan SUVr | Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. | baseline and follow-up scans |