Clinical Evaluation of Flortaucipir F 18

Depression Clinical Trial

Official title:

Clinical Evaluation of 18F-AV-1451

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278367
• Other study ID #: 18F-AV-1451-A14
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: June 26, 2019

Study information

• Verified date: August 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Brain Injuries
• Brain Injuries, Traumatic
• Depression
• Traumatic Brain Injury

Intervention

Drug:
• Flortaucipir F18
IV injection, 370 MBq (10 mCi), up to two doses

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain

Locations

Country	Name	City	State
United States	Center for Vital Longevity at the University of Texas at Dallas	Dallas	Texas
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner Alzheimer's Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events Related to Flortaucipir Administration	Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.; (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).	within 48 hours of drug administration
Primary	Flortaucipir PET Scan SUVr	Standard Uptake Value Ratio (SUVr) using a weighted cortical average. 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 and follow-up scans