- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414347
F 18 T807 Tau PET Imaging of Alzheimer's Disease (T807IND)
May 5, 2023 updated by: Tammie L. S. Benzinger, MD, PhD
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
900
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kelley M Jackson, BA
- Phone Number: 314 362-1558
- Email: kelleyj@wustl.edu
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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Contact:
- Kelley M Jackson
- Phone Number: 314-362-1558
- Email: kelleyj@wustl.edu
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-
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
18 years and older (Adult, Older Adult)
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 -
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Experimental F 18 T807
Participants will undergo a PET scan using the flortaucipir imaging tracer
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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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.
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tammie Benzinger, MD, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gordon 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.
- 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.
- Mishra 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.
- Roe 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.
- Roe 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.
- Strain 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.
- Aschenbrenner 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.
- Pontecorvo 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.
- Zhao 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.
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)
October 23, 2014
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
April 7, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IND 123119 Protocol A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
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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