Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05641688 | [18F]PI-2620 Phase 3 Histopathological Study | PHASE3 | RECRUITING | 200 | — | — | Dec 1, 2022 | Jun 1, 2027 | May 22, 2026 | 25 | United States |
| NCT04715750 | Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity | PHASE1 | COMPLETED | 10 | — | — | Nov 12, 2020 | Oct 26, 2022 | May 18, 2025 | 1 | Germany |
\[18F\]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%.
PI-2620 tau PET images obtained with \[18F\]PI-2620 using high specific activity (185 MBq and ≤ 5 µg mass dose) and with \[18F\]PI-2620 using low specific activity (185 MBq and 40-50 µg mass dose) in AD and PSP patients will be visually analyzed. Visual analysis of the tau signal pattern will be compared for high and low specific activity images within the same subject.
| Arm | Type | Description |
|---|---|---|
| PI-2620 PET Scan | EXPERIMENTAL | - |
| Tau deposition in the brains of Alzheimer Disease and Progressive Supranuclear Palsy patients | EXPERIMENTAL | All patients will receive two administrations of \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose) |
| Name | Type | Description |
|---|---|---|
| [18F]PI-2620 | DRUG | The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20% |
| [18F]-PI2620 | DRUG | \[18F\]PI-2620 is a radioactive diagnostic agent being developed for the indication of PET imaging of the brain to detect tau pathology in adult patients who are being evaluated for neurodegenerative decline. All patients will receive two administrations of \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose). |
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 limit...