Flortaucipir 18F PET Imaging in BIOCARD Study

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Amyloid Negative	Brain PET scan	Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
Amyloid Positive	Brain PET scan	Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
Amyloid Positive	Flortaucipir F18	Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
Amyloid Negative	Flortaucipir F18	Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan

Primary Outcome Measures

Name	Time	Method
Quantitative Evaluation of Scan Results	75 minutes post dose administration	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.
Qualitative Evaluation of Scan Results	Baseline scan	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.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility