Clinical Evaluation of Flortaucipir F 18

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Traumatic Brain Injury; Alzheimer's Disease; Depression

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02278367

18F-AV-1451-A14

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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179 participants in 1 patient group

Flortaucipir PET Scans

Experimental group

Treatment:

Drug: Flortaucipir F18

Procedure: Brain PET scan