Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 23, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT05641688). This is a study registration, not published results. Lead sponsor: Lantheus Biosciences Ltd.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: DRUG: [18F]PI-2620. Primary outcome 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. Brief 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.