Alzheimer DiseaseT807INDNCT02414347
F 18 T807 Tau PET Imaging of Alzheimer's Disease
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- F 18 T807
- Type of treatment
- Injection or infusion
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female participants, at least 18 years of age.
- Cognitively normal, or with mild dementia, as assessed clinically
- 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).
- Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.
Who cannot join
- 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).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- 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.
- Severe claustrophobia.
- Currently pregnant or breast-feeding.
- For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Kelley M Jackson, 314-362-1558, kelleyj@wustl.edu
About this study
Official title: F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- F 18 T807
- Keywords
- Dementia, Tauopathies, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, Nervous System Diseases, Neurodegenerative Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Tauopathies, Brain Diseases, Central Nervous System Diseases, Cognitive Dysfunction, Nervous System Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F 18 T807Drug
Also called 18F-AV-1451
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental F 18 T807 | Participants will undergo a PET scan using the flortaucipir imaging tracer Receives: Drug: F 18 T807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start23 Oct 2014
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
- Investigators
- Tammie Benzinger, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414347
- Sponsor's protocol ID
- IND 123119 Protocol A
- Acronym
- T807IND
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2015
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
Day GS, Gordon BA, Perrin RJ, Cairns NJ, Beaumont H, Schwetye K, Ferguson C, Sinha N, Bucelli R, Musiek ES, Ghoshal N, Ponisio MR, Vincent B, Mishra S, Jackson K, Morris JC, Benzinger TLS, Ances BM. In vivo [18F]-AV-1451 tau-PET imaging in sporadic Creutzfeldt-Jakob disease. Neurology. 2018 Mar 6;90(10):e896-e906. doi: 10.1212/WNL.0000000000005064. Epub 2018 Feb 7.
PubMed 29438042Mishra S, Gordon BA, Su Y, Christensen J, Friedrichsen K, Jackson K, Hornbeck R, Balota DA, Cairns NJ, Morris JC, Ances BM, Benzinger TLS. AV-1451 PET imaging of tau pathology in preclinical Alzheimer disease: Defining a summary measure. Neuroimage. 2017 Nov 1;161:171-178. doi: 10.1016/j.neuroimage.2017.07.050. Epub 2017 Jul 26.
PubMed 28756238Roe CM, Babulal GM, Mishra S, Gordon BA, Stout SH, Ott BR, Carr DB, Ances BM, Morris JC, Benzinger TLS. Tau and Amyloid Positron Emission Tomography Imaging Predict Driving Performance Among Older Adults with and without Preclinical Alzheimer's Disease. J Alzheimers Dis. 2018;61(2):509-513. doi: 10.3233/JAD-170521.
PubMed 29171997Gordon BA, McCullough A, Mishra S, Blazey TM, Su Y, Christensen J, Dincer A, Jackson K, Hornbeck RC, Morris JC, Ances BM, Benzinger TLS. Cross-sectional and longitudinal atrophy is preferentially associated with tau rather than amyloid beta positron emission tomography pathology. Alzheimers Dement (Amst). 2018 Mar 6;10:245-252. doi: 10.1016/j.dadm.2018.02.003. eCollection 2018.
PubMed 29780869Roe CM, Babulal GM, Stout SH, Ott BR, Carr DB, Williams MM, Benzinger TLS, Fagan AM, Holtzman DM, Ances BM, Morris JC. Using the A/T/N Framework to Examine Driving in Preclinical AD. Geriatrics (Basel). 2018 Jun;3(2):23. doi: 10.3390/geriatrics3020023. Epub 2018 May 2.
PubMed 29805967Strain JF, Smith RX, Beaumont H, Roe CM, Gordon BA, Mishra S, Adeyemo B, Christensen JJ, Su Y, Morris JC, Benzinger TLS, Ances BM. Loss of white matter integrity reflects tau accumulation in Alzheimer disease defined regions. Neurology. 2018 Jul 24;91(4):e313-e318. doi: 10.1212/WNL.0000000000005864. Epub 2018 Jun 29.
PubMed 29959265Aschenbrenner AJ, Gordon BA, Benzinger TLS, Morris JC, Hassenstab JJ. Influence of tau PET, amyloid PET, and hippocampal volume on cognition in Alzheimer disease. Neurology. 2018 Aug 28;91(9):e859-e866. doi: 10.1212/WNL.0000000000006075. Epub 2018 Aug 1.
PubMed 30068637Pontecorvo MJ, Devous MD Sr, Navitsky M, Lu M, Salloway S, Schaerf FW, Jennings D, Arora AK, McGeehan A, Lim NC, Xiong H, Joshi AD, Siderowf A, Mintun MA; 18F-AV-1451-A05 investigators. Relationships between flortaucipir PET tau binding and amyloid burden, clinical diagnosis, age and cognition. Brain. 2017 Mar 1;140(3):748-763. doi: 10.1093/brain/aww334.
PubMed 28077397Zhao Y, Raichle ME, Wen J, Benzinger TL, Fagan AM, Hassenstab J, Vlassenko AG, Luo J, Cairns NJ, Christensen JJ, Morris JC, Yablonskiy DA. In vivo detection of microstructural correlates of brain pathology in preclinical and early Alzheimer Disease with magnetic resonance imaging. Neuroimage. 2017 Mar 1;148:296-304. doi: 10.1016/j.neuroimage.2016.12.026. Epub 2016 Dec 15.
PubMed 27989773
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
- ClinicalTrials.gov ID
- NCT02414347
- Acronym / sponsor ID
- T807IND / IND 123119 Protocol A
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Tauopathies, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, Nervous System Diseases, Neurodegenerative Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Tammie L. S. Benzinger, MD, PhDUniversity, hospital or other
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental F 18 T807 | – | Drug: F 18 T807Participants will undergo a PET scan using the flortaucipir imaging tracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Male or female participants, at least 18 years of age.
- Cognitively normal, or with mild dementia, as assessed clinically
- 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).
- Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.
Key exclusion criteria (8 listed)
- 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).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F 18 T807Also: 18F-AV-1451Participants 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. | Drug | Experimental F 18 T807 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 29438042Day GS, Gordon BA, Perrin RJ, Cairns NJ, Beaumont H, Schwetye K, Ferguson C, Sinha N, Bucelli R, Musiek ES, Ghoshal N, Ponisio MR, Vincent B, Mishra S, Jackson K, Morris JC, Benzinger TLS, Ances BM. In vivo [18F]-AV-1451 tau-PET imaging in sporadic Creutzfeldt-Jakob disease. Neurology. 2018 Mar 6;90(10):e896-e906. doi: 10.1212/WNL.0000000000005064. Epub 2018 Feb 7.
- Background: PubMed 28756238Mishra S, Gordon BA, Su Y, Christensen J, Friedrichsen K, Jackson K, Hornbeck R, Balota DA, Cairns NJ, Morris JC, Ances BM, Benzinger TLS. AV-1451 PET imaging of tau pathology in preclinical Alzheimer disease: Defining a summary measure. Neuroimage. 2017 Nov 1;161:171-178. doi: 10.1016/j.neuroimage.2017.07.050. Epub 2017 Jul 26.
- Background: PubMed 29171997Roe CM, Babulal GM, Mishra S, Gordon BA, Stout SH, Ott BR, Carr DB, Ances BM, Morris JC, Benzinger TLS. Tau and Amyloid Positron Emission Tomography Imaging Predict Driving Performance Among Older Adults with and without Preclinical Alzheimer's Disease. J Alzheimers Dis. 2018;61(2):509-513. doi: 10.3233/JAD-170521.
- Background: PubMed 29780869Gordon BA, McCullough A, Mishra S, Blazey TM, Su Y, Christensen J, Dincer A, Jackson K, Hornbeck RC, Morris JC, Ances BM, Benzinger TLS. Cross-sectional and longitudinal atrophy is preferentially associated with tau rather than amyloid beta positron emission tomography pathology. Alzheimers Dement (Amst). 2018 Mar 6;10:245-252. doi: 10.1016/j.dadm.2018.02.003. eCollection 2018.
- Background: PubMed 29805967Roe CM, Babulal GM, Stout SH, Ott BR, Carr DB, Williams MM, Benzinger TLS, Fagan AM, Holtzman DM, Ances BM, Morris JC. Using the A/T/N Framework to Examine Driving in Preclinical AD. Geriatrics (Basel). 2018 Jun;3(2):23. doi: 10.3390/geriatrics3020023. Epub 2018 May 2.
- Background: PubMed 29959265Strain JF, Smith RX, Beaumont H, Roe CM, Gordon BA, Mishra S, Adeyemo B, Christensen JJ, Su Y, Morris JC, Benzinger TLS, Ances BM. Loss of white matter integrity reflects tau accumulation in Alzheimer disease defined regions. Neurology. 2018 Jul 24;91(4):e313-e318. doi: 10.1212/WNL.0000000000005864. Epub 2018 Jun 29.
- Background: PubMed 30068637Aschenbrenner AJ, Gordon BA, Benzinger TLS, Morris JC, Hassenstab JJ. Influence of tau PET, amyloid PET, and hippocampal volume on cognition in Alzheimer disease. Neurology. 2018 Aug 28;91(9):e859-e866. doi: 10.1212/WNL.0000000000006075. Epub 2018 Aug 1.
- Background: PubMed 28077397Pontecorvo MJ, Devous MD Sr, Navitsky M, Lu M, Salloway S, Schaerf FW, Jennings D, Arora AK, McGeehan A, Lim NC, Xiong H, Joshi AD, Siderowf A, Mintun MA; 18F-AV-1451-A05 investigators. Relationships between flortaucipir PET tau binding and amyloid burden, clinical diagnosis, age and cognition. Brain. 2017 Mar 1;140(3):748-763. doi: 10.1093/brain/aww334.
- Background: PubMed 27989773Zhao Y, Raichle ME, Wen J, Benzinger TL, Fagan AM, Hassenstab J, Vlassenko AG, Luo J, Cairns NJ, Christensen JJ, Morris JC, Yablonskiy DA. In vivo detection of microstructural correlates of brain pathology in preclinical and early Alzheimer Disease with magnetic resonance imaging. Neuroimage. 2017 Mar 1;148:296-304. doi: 10.1016/j.neuroimage.2016.12.026. Epub 2016 Dec 15.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tammie Benzinger, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Tammie L. S. Benzinger, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelley M Jackson, BA (314 362-1558, kelleyj@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414347, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.