Flortaucipir 18F PET Imaging in BIOCARD Study

Avid Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Cognitive Decline

Treatments: Procedure: Brain PET scan; Drug: Flortaucipir F18

Study type: Interventional

Funder types: Industry

Identifiers

NCT03052972

18F-AV-1451-A20

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Amyloid Positive

Experimental group

Description:

Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18

Amyloid Negative

Experimental group

Description:

Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18