Clinical Evaluation of Flortaucipir F 18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-06-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease Traumatic Brain Injury Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Flortaucipir PET Scans

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

IV injection, 370 MBq (10 mCi), up to two doses

Brain PET scan

Intervention Type PROCEDURE

positron emission tomography (PET) scan of the brain

Interventions

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Flortaucipir F18

IV injection, 370 MBq (10 mCi), up to two doses

Intervention Type DRUG

Brain PET scan

positron emission tomography (PET) scan of the brain

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes