Flortaucipir 18F PET Imaging in BIOCARD Study

Study Overview
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Brief Summary
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This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.

Official Title
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Flortaucipir (18F) PET Imaging in the BIOCARD Study

Conditions
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Cognitive Decline

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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Inclusion Criteria: Males or females that have provided consent and are currently enrolled in BIOCARD study Ability to tolerate PET scan procedures Ability to provide informed consent for study procedures Exclusion Criteria: Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation. Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females). Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods. Has hypersensitivity to flortaucipir Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator. Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit. Is unsuitable for a study of this type in the opinion of the investigator.
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amyloid Positive<br>Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan | Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain<br>|
| Experimental: Amyloid Negative<br>Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan | Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose<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 |
| --- | --- | --- |
| Qualitative Evaluation of Scan Results | Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions. | Baseline scan | 
| Quantitative Evaluation of Scan Results | Standard Uptake Value Ratio (SUVr) by amyloid status 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. | 75 minutes post dose administration |