Flortaucipir PET Imaging in Subjects With FTD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2018-10-24

Brief Summary

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This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).

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Detailed Description

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Conditions

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Frontotemporal Dementia

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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FTD Subjects

Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq)(10 millicurie \[mCi\]) injection, 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 \[mCi\]) injection, 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

* Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
* Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
* Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
* Can tolerate PET scan procedures

Exclusion Criteria

* Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
* Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
* Have history of drug or alcohol dependence within the last year
* Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
* Have history of relevant severe drug allergy or hypersensitivity
* Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
* Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
* Possess PET scan evidence of amyloid deposition
* Determined by the investigator to be unsuitable for this type of study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No