search
Back to results

Flortaucipir 18F PET Imaging in BIOCARD Study

Primary Purpose

Cognitive Decline

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Flortaucipir F18
Brain PET scan
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cognitive Decline

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Amyloid Positive

Amyloid Negative

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2017
Last Updated
September 3, 2020
Sponsor
Avid Radiopharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT03052972
Brief Title
Flortaucipir 18F PET Imaging in BIOCARD Study
Official Title
Flortaucipir (18F) PET Imaging in the BIOCARD Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
study terminated due to lower than expected enrollment
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amyloid Positive
Arm Type
Experimental
Arm Description
Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan
Arm Title
Amyloid Negative
Arm Type
Experimental
Arm Description
Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
18F-AV-1451, [F-18]T807, LY3191748, Tauvid
Intervention Description
370 megabecquerel (MBq)(10 millicurie [mCi]) single dose
Intervention Type
Procedure
Intervention Name(s)
Brain PET scan
Intervention Description
positron emission tomography (PET) scan of the brain
Primary Outcome Measure Information:
Title
Qualitative Evaluation of Scan Results
Description
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.
Time Frame
Baseline scan
Title
Quantitative Evaluation of Scan Results
Description
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.
Time Frame
75 minutes post dose administration

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.jhsph.edu/faculty/research/search/results/project/8899
Description
BIOCARD Study Summary

Learn more about this trial

Flortaucipir 18F PET Imaging in BIOCARD Study

We'll reach out to this number within 24 hrs