Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

September 3, 2020 updated by: Avid Radiopharmaceuticals

An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan

This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Center for Clinical Imaging Research, Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a previous 18F-AV-1451 brain scan
  • Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
  • Ability to provide informed consent

Exclusion Criteria:

  • Current clinically significant psychiatric disease
  • Are claustrophobic
  • Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
  • Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follow-up Flortaucipir PET Scan
Procedure: Brain PET Scan
positron emission tomography (PET) scan of the brain
Drug: Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
Drug: Florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • Amyvid
  • 18F-AV-45

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tau Deposition
Time Frame: baseline scan and at least 6 months after baseline scan
Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
baseline scan and at least 6 months after baseline scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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