Back to resultsClinical Evaluation of Flortaucipir F 18
Primary Purpose
Alzheimer's Disease, Traumatic Brain Injury, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Flortaucipir F18
Brain PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
Eligibility Criteria
Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
Inclusion Criteria:
- Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Exclusion Criteria:
- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have a history of relevant severe drug allergy or hypersensitivity
- Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
- Are patients with current clinically significant unstable medical comorbidities
- Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Sites / Locations
- Banner Alzheimer's Institute
- Yale University
- Cleveland Clinic Lou Ruvo Center for Brain Health
- University of Pennsylvania
- Center for Vital Longevity at the University of Texas at Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flortaucipir PET Scans
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events Related to Flortaucipir Administration
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.
(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
Flortaucipir PET Scan SUVr
Standard Uptake Value Ratio (SUVr) 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
NCT ID
NCT02278367
First Posted
October 28, 2014
Last Updated
August 21, 2020
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02278367
Brief Title
Clinical Evaluation of Flortaucipir F 18
Official Title
Clinical Evaluation of 18F-AV-1451
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Traumatic Brain Injury, Depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flortaucipir PET Scans
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
[F-18]T807, 18F-AV-1451, LY3191748, Tauvid
Intervention Description
IV injection, 370 MBq (10 mCi), up to two doses
Intervention Type
Procedure
Intervention Name(s)
Brain PET scan
Intervention Description
positron emission tomography (PET) scan of the brain
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events Related to Flortaucipir Administration
Description
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.
(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
Time Frame
within 48 hours of drug administration
Title
Flortaucipir PET Scan SUVr
Description
Standard Uptake Value Ratio (SUVr) 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
baseline and follow-up scans
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
Inclusion Criteria:
Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Exclusion Criteria:
Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Have a history of relevant severe drug allergy or hypersensitivity
Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
Are patients with current clinically significant unstable medical comorbidities
Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Center for Vital Longevity at the University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Flortaucipir F 18
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