Flortaucipir PET Imaging in Subjects With FTD

Study Overview
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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).

Official Title
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18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia

Conditions
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Frontotemporal Dementia

Intervention / Treatment
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* Drug: Flortaucipir F18
* Procedure: Brain PET scan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTD Subjects<br>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 | Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Evaluation of Flortaucipir PET Scans | Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (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. | baseline scan | 
| Quantitative Evaluation of Flortaucipir PET Scans | Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. 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. | baseline scan |