Alzheimer DiseaseAV ADADNCT02414178
F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (DIAN Project)
An observational study of Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a… 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
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Jan 2027
- 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: Participants are enrolled in the "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187) or the DIAN Extended Registry (EXR)
Who may be able to join
- Participants have met all eligibility criteria for enrollment into the "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187) or the DIAN Extended Registry (EXR)
- 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; 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. Only negative pregnancy test result would allow the drug administration to proceed.
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.
Show all 9Show fewer
- Women who are currently pregnant or breast-feeding, and women who do not agree to use reliable contraception, or to refrain from sexcual activity for 24 hours following administration of the flortaucipir injection will be excluded from the study.
- Other than DIAN study, currently participating in any research study and receiving an active study medication for Alzheimer's Disearse, an investigational drug, device, imaging, or placebo within the past 30 days before screening, and throughout this clinical trial up to 2-weeks past any study-related procedures.
- Other than DIAN study, current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1. It is the responsibility of each site to confirm the date of the most recent PET scan and to work within the guidelines of the local Radioactive Drug Research Committee (RDRC) regarding the imaging interval.
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
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND 123119, Protocol D
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cognitive status.
This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI may also be conducted.
Read the detailed description
The investigators hypothesize that in vivo tau imaging will ultimately:
- Demonstrate the presence of tau fibrils in the brain during the pre-symptomatic stages of cognitive decline, prior to cerebral atrophy, hypometabolism (as measured by 18F-FDG PET imaging), and dementia.
- Demonstrate that the phenoconversion from cognitively normal (CN) status to early stages of cognitive impairment will be closely correlated with neocortical F 18 T807 uptake and that amyloid positive CN individuals who are positive for F 18 T807 will demonstrate conversion to early dementia.
- Correlate closely with the appearance of CSF markers of tau, including tau, p-tau, and VILIP-1.
- Co-localize with specific cognitive deficits (i.e. patients with tau deposition in the left lateral temporal lobe will have primarily language deficits).
- Predict the onset of dementia more accurately than existing biomarkers.
- Conditions
- Alzheimer Disease
- Being tested
- F 18 T807
- Keywords
- Dementia, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, nervous system diseases, Neurodegenerative Disease
- Medical subject headings
- Alzheimer Disease, Dementia, 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 | Not described 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.
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 start1 Mar 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT02414178
- Sponsor's protocol ID
- IND 123119 Protocol D
- Acronym
- AV ADAD
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2015
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND 123119, Protocol D
- ClinicalTrials.gov ID
- NCT02414178
- Acronym / sponsor ID
- AV ADAD / IND 123119 Protocol D
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, nervous system diseases, Neurodegenerative Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (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.
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cognitive status.
This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI may also be conducted.
Detailed description
The investigators hypothesize that in vivo tau imaging will ultimately:
- Demonstrate the presence of tau fibrils in the brain during the pre-symptomatic stages of cognitive decline, prior to cerebral atrophy, hypometabolism (as measured by 18F-FDG PET imaging), and dementia.
- Demonstrate that the phenoconversion from cognitively normal (CN) status to early stages of cognitive impairment will be closely correlated with neocortical F 18 T807 uptake and that amyloid positive CN individuals who are positive for F 18 T807 will demonstrate conversion to early dementia.
- Correlate closely with the appearance of CSF markers of tau, including tau, p-tau, and VILIP-1.
- Co-localize with specific cognitive deficits (i.e. patients with tau deposition in the left lateral temporal lobe will have primarily language deficits).
- Predict the onset of dementia more accurately than existing biomarkers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental F 18 T807 | – | Drug: F 18 T807 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are enrolled in the "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187) or the DIAN Extended Registry (EXR)
Key inclusion criteria (5 listed)
- Participants have met all eligibility criteria for enrollment into the "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187) or the DIAN Extended Registry (EXR)
- 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; 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. Only negative pregnancy test result would allow the drug administration to proceed.
Key exclusion criteria (9 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
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 9 Jun 2026.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 Washington University School of Medicine 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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 9 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 9 Jun 2026.