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Also known as [18F]-PI2620
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 is an investigational small molecule PET imaging agent being developed by Lantheus Holdings, Inc. (ticker: LNTH) for neurology applications. It is designed to bind tau protein in the brain and is being studied in Alzheimer Disease and Progressive Supranuclear Palsy. It is currently in Phase 3 clinical development and has not been approved by the FDA.
PI2620 targets tau, a protein that forms abnormal deposits in the brains of patients with certain neurodegenerative conditions. As a small molecule PET imaging agent, it is intended to visualize tau pathology. This mechanism underlies its investigation in Alzheimer Disease and Progressive Supranuclear Palsy.
PI2620 is being developed by Lantheus Holdings, Inc., which trades under the ticker symbol LNTH. The company is advancing the agent through clinical development for neurology indications, including Alzheimer Disease and Progressive Supranuclear Palsy.
PI2620 is in Phase 3 clinical development. A Phase 3 histopathological study in Alzheimer Disease is currently recruiting, while earlier Phase 1 studies in Progressive Supranuclear Palsy and in Alzheimer Disease and Progressive Supranuclear Palsy have been completed. PI2620 is investigational and has not been approved by the FDA.
PI2620 has been evaluated in clinical trials including NCT05641688, a Phase 3 histopathological study in Alzheimer Disease that is recruiting with an estimated enrollment of 200 participants in the United States. Completed studies include NCT05187546 in Progressive Supranuclear Palsy and NCT04715750 in Alzheimer Disease and Progressive Supranuclear Palsy.
Yes, PI2620 is also known as [18F]-PI2620, [18F]PI-2620, and PI-2620. These names refer to the same investigational tau-targeting PET imaging agent developed by Lantheus Holdings, Inc. (LNTH) for Alzheimer Disease and Progressive Supranuclear Palsy.