F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (DIAN Project)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND #123119 Protocol D)|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2015|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||February 2020 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02414178
|Contact: Trish Stevenson, MS, CCRC||314 firstname.lastname@example.org|
|Contact: Kelley Jackson, BA||314 email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Trish Stevenson 314-362-3613 firstname.lastname@example.org|
|Contact: Kelley Jackson 314 362-6737 email@example.com|
|Principal Investigator:||Tammie Benzinger, MD, PhD||Washington University School of Medicine|