Clinical Evaluation of Flortaucipir F 18

Phase 2

Completed

• Conditions: Depression; Alzheimer's Disease; Traumatic Brain Injury
• Interventions: Drug: Flortaucipir F18; Procedure: Brain PET scan

• Registration Number: NCT02278367
• Lead Sponsor: Avid Radiopharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-30
• Study Start: 2014-12
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Results First Submitted: 2020-07-15
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Results First Posted: 2020-09-10
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flortaucipir PET Scans	Brain PET scan	-
Flortaucipir PET Scans	Flortaucipir F18	-

Primary Outcome Measures

Name	Time	Method
Flortaucipir PET Scan SUVr	baseline and follow-up scans	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.
Number of Participants With Adverse Events Related to Flortaucipir Administration	within 48 hours of drug 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).

Trial Locations

Locations (5)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Cleveland Clinic Lou Ruvo Center for Brain Health; 🇺🇸 Las Vegas, Nevada, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Center for Vital Longevity at the University of Texas at Dallas; 🇺🇸 Dallas, Texas, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States