Brain Tau PET Histopathological Study
Study Title: An Open-label, Non-randomized, Multi-center Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of PET Imaging With [18F]PI-2620 for the Detection of Tau Deposition When Compared to Post-mortem Histopathology (ADvance).
Purpose
In this investigation, the drug [18F]PI-2620 is being tested for its usefulness in medical imaging studies to help look for a type of protein in the brain, called tau. [18F]PI-2620 is a compound with a low level of radioactivity attached, for use with positron emission tomography (PET), a type of medical test that resembles getting a CT or CAT scan. PET scanning enables us to see the presence, amounts and locations of certain types of molecules in the brain, and [18F]PI-2620 is being tested for its safety and accuracy in identifying and locating tau molecules. During this study participants will be asked to attend a screening visit to assess their health before receiving an injection of a small amount of [18F]PI-2620, a brain scan for 30 minutes, starting 45 minutes after receiving [18F]PI-2620, and a safety follow up phone call 7 days after the brain scan. Additionally, if any participants die in the months or years after undergoing the scan, their brain tissue will be autopsied and analyzed for presence, location and amounts of protein it may contain so that it can be compared to the PET scan results.
Inclusion criteria:
- Males and females aged 50 years and over
- Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limited to end-stage dementia, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease (COPD), or end-stage cancer)
- Written informed consent obtained from the subject and/or the subject’s legally authorized representative (LAR), as applicable, to consent for study procedures and brain donation (consent consistent with the legal requirements of the State in which the subject dies)
- Can tolerate study procedures including lying down in PET scanner. The investigator will carefully assess each subject and use medical judgment to determine whether the subject can tolerate the imaging procedure.
(PI: Daniel Silverman, MD, PhD)
Contact: Dr. Daniel Silverman at (310) 794-5067 to participate or for more information.
More information on the [18F]PI-2620 Phase 3 Histopathological study is available at clinicaltrials.gov ID#: NCT05641688.