Flortaucipir 18F PET Imaging in BIOCARD Study

Flortaucipir (18F) PET Imaging in the BIOCARD Study

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.

Study Overview

• Status: Terminated
• Conditions: Cognitive Decline
• Intervention / Treatment: Drug: Flortaucipir F18; Procedure: Brain PET scan

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amyloid Positive; Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan	Drug: Flortaucipir F18; 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose; Other Names: 18F-AV-1451; [F-18]T807; LY3191748; Tauvid; Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain
Experimental: Amyloid Negative; Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan	Drug: Flortaucipir F18; 370 megabecquerel (MBq)(10 millicurie [mCi]) single dose; Other Names: 18F-AV-1451; [F-18]T807; LY3191748; Tauvid; Procedure: Brain PET scan; positron emission tomography (PET) scan of the brain

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals
• Investigators: Study Chair: Medical Director, Avid Radiopharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): August 17, 2018

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 18F-AV-1451-A20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No