Flortaucipir PET Imaging in Subjects With FTD

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

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