Phase 3 Study of [18F]PI-2620 for Alzheimer's Disease
This study is testing a special imaging agent called [18F]PI-2620. It's given through an IV and helps doctors see tau deposits in the brain using a PET scan. Tau deposits are a sign of Alzheimer's disease. Researchers want to see how well [18F]PI-2620 PET scans can find these tau deposits in people with Alzheimer's and compare the results to brain tissue examined after death. You might be able to join if you are 50 or older and have a life expectancy of one year or less due to a serious medical condition. The study aims to enroll 200 participants, but its current status is unclear.
- Study design
- This is an open-label, multi-center study, meaning both you and the study team will know what treatment you are receiving. It is a Phase 3 study and aims to enroll 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal is measured at autopsy, which will happen until the study is complete, averaging about one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
[18F]PI-2620 Phase 3 Histopathological Study
At a glance
Conditions
Where it's being run
25 sites across 10 statesStudy leadership
- Alireza Atri, MD, PhD · PRINCIPAL_INVESTIGATOR · Banner Health
- Andrew Stephens, MD, PhD · STUDY_DIRECTOR · Life Molecular Imaging
Who to contact
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What this trial measures
- Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)At autopsy, until study completion with an average of 1 year
\[18F\]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0 or B1 or positive NFT Scores of B2 or B3. The \[18F\]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.