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)
Life Molecular Imaging Ltd
Summary
This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Only subjects who meet all of the following criteria will be eligible for enrollment into the study: 1. Males and females aged 50 years and over 2. 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) 3. Written informed consent obtained from the subject and/or the subject's legally authorized representative (LAR), as applicable, to consent for study procedure…
Interventions
- Drug[18F]PI-2620
The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
Locations (25)
- Barrow Neurological InstitutePhoenix, Arizona
- Banner Sun Health Research InstituteSun City, Arizona
- UC Los AngelesLos Angeles, California
- Esperanza ClinicalMurrieta, California
- Sutter HealthSan Francisco, California
- Galiz ResearchHialeah, Florida