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F 18 T807 Tau PET Imaging of Alzheimer's Disease (T807IND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02414347
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : May 8, 2023
Information provided by (Responsible Party):
Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine

Brief Summary:
A single-center, open-label baseline controlled imaging study designed to assess whether brain tau fibril uptake of flortaucipir as measured by PET correlates with cognitive status of individuals with and without brain tau fibrils.

Condition or disease Intervention/treatment
Alzheimer Disease Drug: F 18 T807

Detailed Description:
This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with and without brain tau fibrils. The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
Actual Study Start Date : October 23, 2014
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

Group/Cohort Intervention/treatment
Experimental F 18 T807
Participants will undergo a PET scan using the flortaucipir imaging tracer
Drug: F 18 T807
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
Other Name: 18F-AV-1451

Primary Outcome Measures :
  1. F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance. [ Time Frame: 5 years ]
    Employing statistical parametric mapping (SPM), a voxel-based analytic measure in order to quantify and co-localize the imaging patterns from the multiple imaging datasets in this study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One hundred (100) participants over a period of approximately 5 years will be enrolled. Participants will undergo an F 18 T807 scan at the Center for Clinical Imaging Research (CCIR) at Washington University using an adaption of the protocol developed by Kolb and colleagues [7]. An MRI may be conducted if one has not been completed within the past 12 months under a related research study.

Inclusion Criteria:

  1. Male or female participants, at least 18 years of age.
  2. Cognitively normal, or with mild dementia, as assessed clinically
  3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
  4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion Criteria:

  1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
  2. Is deemed likely unable to perform the imaging procedures for any reason.
  3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
  4. Has hypersensitivity to F 18 T807 or any of its excipients.
  5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
  6. Severe claustrophobia.
  7. Currently pregnant or breast-feeding.
  8. For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -

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): NCT02414347

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Contact: Kelley M Jackson, BA 314 362-1558 kelleyj@wustl.edu

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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelley M Jackson    314-362-1558    kelleyj@wustl.edu   
Sponsors and Collaborators
Tammie L. S. Benzinger, MD, PhD
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Principal Investigator: Tammie Benzinger, MD, PhD Washington University School of Medicine

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Responsible Party: Tammie L. S. Benzinger, MD, PhD, Professor of Radiology & Neurological Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02414347    
Other Study ID Numbers: IND 123119 Protocol A
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: May 8, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share the data with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. The participant"s individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at this information.
Keywords provided by Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine:
Brain Diseases
Central Nervous System Diseases
Mild Cognitive Impairment
Nervous System Diseases
Neurodegenerative Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders