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

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ClinicalTrials.gov Identifier: NCT02051764
Recruitment Status : Terminated (Lower than expected enrollment)
First Posted : January 31, 2014
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Flortaucipir F18 Drug: Florbetapir F 18 Procedure: Brain PET Scan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Follow-up Flortaucipir PET Scan Drug: Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • 18F-AV-1451
  • LY3191748
  • [F-18]T807

Drug: Florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • Amyvid
  • 18F-AV-45

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051764


Locations
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United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Center for Clinical Imaging Research, Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02051764    
Other Study ID Numbers: 18F-AV-1451-A04
First Posted: January 31, 2014    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders