Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02676843|
Recruitment Status : Completed
First Posted : February 8, 2016
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Frontotemporal Lobar Degeneration (FTLD) Frontotemporal Dementia (FTD) Tauopathies||Drug: 18F-AV-1451||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||November 25, 2018|
|Actual Study Completion Date :||November 25, 2018|
Subjects who are microtubule associated protein tau (MAPT) family carriers and non-carriers will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
Other Name: [18F]AV-1451
- SUVR of 18F-AV-1451 [ Time Frame: Baseline, 12-month follow up ]Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.
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): NCT02676843
|United States, New York|
|Morton A. Kreitchman PET Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Edward Huey, MD||Columbia University|