NCT03143374

PET Tau - Neurodegenerative Disease Imaging

Positron Emission Tomography (PET) Imaging of Tau Pathology in Neurodegenerative Disease

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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. This study looks at neurodegenerative diseases such as frontotemporal degeneration (FTD).

Detailed description

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-AV-1451 (formally known as 18F-T807) is a specialized radioactive PET tracer that sticks to the tau protein in the brain. In this study, researchers will use 18F-AV-1451 to form images of tau binding in the brain. 18F-AV-1451 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-AV-1451 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.

Conditions

• Neurodegenerative Disease

Interventions

Type	Name	Description
DRUG	18F-AV-1451	The experimental tracer used for this study is called 18F-AV-1451 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain. Participants will undergo a baseline 18F-AV-1451 brain scan. If funding is available, participants will be asked to return for one or more longitudinal visits, including a 18F-AV-1451 brain scan, every 9 to 18 months after the prior visit. The 18F-AV-1451 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.

Timeline

• Start date: 2016-08-23
• Primary completion: 2030-09-01
• Completion: 2030-09-01
• First posted: 2017-05-08
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study