Flortaucipir 18F PET Imaging in BIOCARD Study



Status:Terminated
Conditions:Cognitive Studies, Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:12/12/2018
Start Date:March 23, 2017
End Date:August 17, 2018

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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.


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 ECG acquired prior to initial 18F-AV-1451 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 18F-AV-1451.

- 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 18F-AV-1451 imaging visit.

- Is unsuitable for a study of this type in the opinion of the investigator.
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Marilyn Albert, PhD
Phone: 410-955-1911
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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