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[18F]PI-2620 Phase 3 Histopathological Study

NCT05641688 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[18F]PI-2620

The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%

Sponsors & Collaborators

  • Lantheus Biosciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Alireza Atri, MD, PhD · Banner Health

  • Andrew Stephens, MD, PhD · Life Molecular Imaging

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641688 on ClinicalTrials.gov