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Flortaucipir 18F PET Imaging in BIOCARD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052972
Recruitment Status : Terminated (study terminated due to lower than expected enrollment)
First Posted : February 14, 2017
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Drug: Flortaucipir F18 Procedure: Brain PET scan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Flortaucipir (18F) PET Imaging in the BIOCARD Study
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : August 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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




Primary Outcome Measures :
  1. Qualitative Evaluation of Scan Results [ Time Frame: Baseline scan ]
    Subject scans were visually evaluated by an expert reader into three groups. Advanced 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.

  2. Quantitative Evaluation of Scan Results [ Time Frame: 75 minutes post dose administration ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052972


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Chair: Medical Director Avid Radiopharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Avid Radiopharmaceuticals:
Study Protocol  [PDF] January 20, 2017
Statistical Analysis Plan  [PDF] March 14, 2019

Additional Information:
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT03052972    
Other Study ID Numbers: 18F-AV-1451-A20
First Posted: February 14, 2017    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders