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Also known as [18F]PI-2620, PI-2620
PI2620 · 3 trials · 2 indications
\[18F\]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%.
Test-retest variability of \[18F\]PI-2620 accumulation will be analyzed using quantification
Safety will be evaluated by collection of Adverse Events.
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 | - |
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients | EXPERIMENTAL | All eligible PSP patients will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm. |
| Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects | EXPERIMENTAL | All eligible non-demented control (NDC) subjects will receive two injections of the investigational imaging agent \[18F\]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 NDC subjects will be required to complete the study arm. |
| 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 megabecquerel (MBq). |
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...
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PI2620, also known as [18F]PI-2620, is an investigational small molecule being developed for use in Alzheimer Disease and Progressive Supranuclear Palsy. It is a positron emission tomography (PET) imaging agent designed to evaluate imaging characteristics in these conditions. The drug is currently in Phase 3 clinical development.
PI2620 is a PET imaging agent that targets tau protein aggregates, which are hallmarks of Alzheimer Disease and Progressive Suupranuclear Palsy. By binding to tau, it enables visualization of disease pathology through PET imaging. The drug is being studied to assess its imaging characteristics in patients with these neurodegenerative conditions.
PI2620 is being developed by Lantheus Holdings, Inc., a company traded on NASDAQ under the ticker symbol LNTH. The company is conducting clinical trials to evaluate the imaging agent's safety and effectiveness in patients with Alzheimer Disease and Progressive Supranuclear Palsy.
PI2620 is in Phase 3 clinical development. The most advanced trial is a Phase 3 histopathological study with an enrollment of 200 participants, which is currently recruiting in the United States. Earlier Phase 1 trials have been completed in Germany.
PI2620 has been studied in three clinical trials. NCT04715750 and NCT05187546 were completed Phase 1 studies in Germany. The active Phase 3 trial, NCT05641688, is a histopathological study recruiting 200 participants with Alzheimer Disease in the United States.
Yes, PI2620 is the same as [18F]PI-2620. The drug is referred to by both names in clinical trial documentation. The [18F] designation indicates the radioactive fluorine isotope used in the PET imaging agent, while PI2620 is the shorter identifier for the compound.