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CompletedNCT02414282Protocol EUpdated Jan 19, 2021

F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction (IND 123119, Protocol E)

An observational study in Alzheimer Disease and Progressive Posterior Cortical Dysfunction (PPCD), sponsored by Tammie L. S. Benzinger, MD, PhD. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Tammie L. S. Benzinger, MD, PhD · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
45 Years and older
Sex
All
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Study summary

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 Progressive Posterior Cortical Dysfunction (PPCD) and logopenic variant primary progressive aphasia (lvPPA). 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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Conditions studied

  • Alzheimer Disease
  • Progressive Posterior Cortical Dysfunction (PPCD)

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Keywords

  • Dementia
  • Brain Diseases
  • mild cognitive impairment
  • Central Nervous System Diseases
  • Neurodegenerative Disease
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

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Lead sponsor

Tammie L. S. Benzinger, MD, PhD is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Collaborating physicians and the Knight ADRC Clinical Core will refer participants to the Knight ADRC Research Imaging (KARI) Program for MR and PET imaging to evaluate tau distribution in the brains of cognitively normal and cognitively impaired individuals, with the primary goal of developing this highly promising tau imaging technique as an antecedent biomarker of cognitive decline. We propose to recruit groups of patients with PPCD and lvPPA from the same clinical environment.

Inclusion criteria

  1. Male or female participants, at least 45 years of age.
  2. Clinical diagnosis of PPCD.
  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 have a negative urine pregnancy test within 24 hours of T807 drug administration.

Exclusion criteria

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: on anticoagulant of any form prior to lumbar puncture.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental F 18 T807

    Drug: F 18 T807

Interventions

  • DrugF 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.

    Also known as: 18F-AV-1451

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What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
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References and documents

Publications

  • Day GS, Gordon BA, Jackson K, Christensen JJ, Rosana Ponisio M, Su Y, Ances BM, Benzinger TLS, Morris JC. Tau-PET Binding Distinguishes Patients With Early-stage Posterior Cortical Atrophy From Amnestic Alzheimer Disease Dementia. Alzheimer Dis Assoc Disord. 2017 Apr-Jun;31(2):87-93. doi: 10.1097/WAD.0000000000000196. PubMed 28394771 ↗

Individual participant data

Plan to share: Yes — We will share this 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 your research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the 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 the information.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02414282
Lead sponsor
Tammie L. S. Benzinger, MD, PhD
Responsible party
Tammie L. S. Benzinger, MD, PhD (Professor of Radiology & Neurological Surgery, Washington University School of Medicine) — Sponsor-investigator
First posted
Apr 10, 2015
Start date
Mar 2015
Primary completion
Oct 20, 2020
Completion
Oct 20, 2020
Last update
Jan 19, 2021

Study contacts

Tammie Benzinger, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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