study terminated due to lower than expected enrollment

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.

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.

AEs were collected at scan visits and for 48 hours after flortaucipir administration.

Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.

Due to slower than expected enrollment, the study was terminated before 100 subjects were recruited.