Flortaucipir PET Imaging in Subjects With FTD

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Frontotemporal Dementia

Treatments: Procedure: Brain PET scan; Drug: Flortaucipir F18

Study type: Interventional

Funder types: Industry

Identifiers

NCT03040713

18F-AV-1451-A19

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

FTD Subjects

Experimental group

Description:

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

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18