Clinical Evaluation of Flortaucipir F 18

NCT02278367 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18F-AV-1451-A14
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 5

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.

Conditions

Alzheimer's Disease; Traumatic Brain Injury; Depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Flortaucipir PET Scans

EXPERIMENTAL

Drug: Flortaucipir F18; Procedure: Brain PET scan

Interventions

Flortaucipir F18 DRUG

IV injection, 370 MBq (10 mCi), up to two doses

Also known as: [F-18]T807, 18F-AV-1451, LY3191748, Tauvid

Flortaucipir PET Scans

Brain PET scan PROCEDURE

positron emission tomography (PET) scan of the brain

Flortaucipir PET Scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (5)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Center for Vital Longevity at the University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Brain Injuries, Traumatic; Depression

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Medical Director
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: December 1, 2014
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-08

Locations

US (5)