drugset / Trial / NCT05641688

[18F]PI-2620 Phase 3 Histopathological Study

NCT05641688 ↗

Phase 3 Recruiting 200 enrolled Lantheus Biosciences Ltd.
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2022-12-01
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject [18F]PI-2620 Diagnostic / imaging agent 185 mbq Intravenous

Indications