F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (DIAN Project) (AV ADAD)
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|ClinicalTrials.gov Identifier: NCT02414178|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2015
Last Update Posted : July 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: F 18 T807||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND 123119, Protocol D|
|Actual Study Start Date :||March 20, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||September 2021|
|Experimental: Experimental F 18 T807||
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
- 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 ]
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): NCT02414178
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Tammie Benzinger, MD, PhD||Washington University School of Medicine|