PET Tau - Neurodegenerative Disease Imaging
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|ClinicalTrials.gov Identifier: NCT03143374|
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment|
|Parkinson Disease||Device: [18F]T807 (also known as 18F-AV- 1451)|
The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). Tau has been shown to build up in the brains of patients with injury to brain cells, including Alzheimer's disease, Parkinson's disease, Lewy body disease and Frontotemporal degeneration. [18F]T807 (also known as 18F-AV- 1451) is a specialized radioactive PET tracer that sticks to the tau protein in the brain. In this study, researchers will use [18F]T807 to form images of tau binding in the brain. [18F]T807 is an investigational or experimental imaging agent that has not yet been approved by the Food and Drug Administration for use in brain imaging.
In this study, researchers want to find out how accurate and useful [18F]T807 is in imaging patients who have problems with thinking, remembering, speech, and visual activities, and may be diagnosed with different types of neurodegenerative disease. This study will help test how imaging measures may provide information that could be used to determine diagnosis for patients in the future. The results of the PET/CT scan will be compared with other information obtained under related protocols, including brain magnetic resonance imaging (MRI), spinal fluid and cognitive test results.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Positron Emission Tomography (PET) Imaging of Tau Pathology in Neurodegenerative Disease|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
- Device: [18F]T807 (also known as 18F-AV- 1451)
experimental PET/CT scan of the brain. In this scan, imaging is done with specialized cameras that can pick up radiation signals given off by a radioactive tracer and determine where the signals come from.
The tracer used for this study is called FT807 (also known as 18F-AV-1451). FT807 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain. FT807 is an experimental tracer that has been studied in patients with known or suspected Alzheimer's disease, Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBS/CBD). In this study, patients will have one (1) [18F]T807 PET/CT scan performed at the University of Pennsylvania. The [18F]T807 PET/CT scan will require up to 3 hours of time, including preparation. The scan will take place using PET/CT scanners in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania.
- Regional uptake [ Time Frame: 2 years ]regional anatomic distribution of PET-tau uptake in dementia syndromes and PET-Tau uptake with neuropsychology and MRI regional GM atrophy at baseline.
- Changes over time [ Time Frame: 2 years ]longitudinal neuropsychological and regional MRI decline in dementia syndromes compared to baseline regional PET-tau uptake
- Tau protein biomarkers [ Time Frame: 2 years ]CSF total and phosphorylated (p-tau/t-tau) tau and regional PET-tau uptake in dementia syndromes
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): NCT03143374
|Contact: Frederick Nitchie, MSfirstname.lastname@example.org|
|Contact: Annabess Ehrhardt, BAemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Frederick Nitchie, MS 215-573-6319 firstname.lastname@example.org|
|Principal Investigator: Murray Grossman, PhD, MD|
|Principal Investigator:||Murray Grossman, PhD, MD||University of Pennsylvania|