[18F]PI-2620 Phase 3 Histopathological Study

Exclusion Criteria

• •Subjects will be excluded from the enrollment if they:
• •1. Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
• •2. Are known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment (e.g. lesions are typically \> 2 cm at their greatest extent and may include stroke, primary or metastatic neoplasm, other tumors or cystic lesions. Subjects with a history of major stroke or traumatic brain injury or other structural lesion as well as cases with a history of primary Central Nervous System (CNS) neoplasm or known metastatic cancer must be discussed with the study sponsor prior to enrollment)
• •3. Have suspected encephalopathy due to alcoholism or end-stage liver disease
• •4. Are known to have a Glomerular Filtration Rate below \< 15 mL/min
• •5. Have received an investigational or approved therapy directly targeting amyloid or tau
• •6. Are females of childbearing potential who are pregnant, lactating or breastfeeding, or who are not using adequate contraception
• •7. Have implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI (in case an MRI is planned to be performed)