Flortaucipir 18F PET Imaging in BIOCARD Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-08-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Decline

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Amyloid Positive

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

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq)(10 millicurie \[mCi\]) single dose

Brain PET scan

Intervention Type PROCEDURE

positron emission tomography (PET) scan of the brain

Amyloid Negative

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

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq)(10 millicurie \[mCi\]) single dose

Brain PET scan

Intervention Type PROCEDURE

positron emission tomography (PET) scan of the brain

Interventions

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Flortaucipir F18

370 megabecquerel (MBq)(10 millicurie \[mCi\]) single dose

Intervention Type DRUG

Brain PET scan

positron emission tomography (PET) scan of the brain

Intervention Type PROCEDURE

Other Intervention Names

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18F-AV-1451 [F-18]T807 LY3191748 Tauvid

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes