F 18 T807 Tau PET Imaging of Alzheimer's Disease (T807IND)
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| ClinicalTrials.gov Identifier: NCT02414347 |
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Recruitment Status :
Recruiting
First Posted : April 10, 2015
Last Update Posted : May 8, 2023
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Sponsor:
Tammie L. S. Benzinger, MD, PhD
Information provided by (Responsible Party):
Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
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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 |
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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
| 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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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 :
- 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.
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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.
Criteria
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 -
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
Contacts
| Contact: Kelley M Jackson, BA | 314 362-1558 | kelleyj@wustl.edu |
Locations
| 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
Investigators
| Principal Investigator: | Tammie Benzinger, MD, PhD | Washington University School of Medicine |
Publications:
| 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:
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Dementia Tauopathies Brain Diseases Central Nervous System Diseases |
Mild Cognitive Impairment Nervous System Diseases Neurodegenerative Disease |
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 |