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RECRUITING
NCT05641688
PHASE3

[18F]PI-2620 Phase 3 Histopathological Study

Sponsor: Life Molecular Imaging Ltd

View on ClinicalTrials.gov

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.

Official title: An Open-label, Non-randomized, Multi-center Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of PET Imaging With [18F]PI-2620 for the Detection of Tau Deposition When Compared to Post-mortem Histopathology (ADvance)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-12-01

Completion Date

2027-06

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

[18F]PI-2620

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

Locations (25)

Barrow Neurological Institute

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

UC Los Angeles

Los Angeles, California, United States

Esperanza Clinical

Murrieta, California, United States

Sutter Health

San Francisco, California, United States

Galiz Research

Hialeah, Florida, United States

UF College of Medicine - Jacksonville

Jacksonville, Florida, United States

K2 Medical Research

Lady Lake, Florida, United States

K2 Medical Research

Maitland, Florida, United States

ClinCloud Research

Melbourne, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

The Roskamp Institute

Sarasota, Florida, United States

Charter Research

Winter Park, Florida, United States

Alzheimer's Disease Center

Braintree, Massachusetts, United States

Headlands Research

Plymouth, Massachusetts, United States

Be Well Clinical Studies

Lincoln, Nebraska, United States

Darthmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Velocity Clinical Research

East Syracuse, New York, United States

Ichor Research

Syracuse, New York, United States

American Carolina Clinical Research LLC

Charlotte, North Carolina, United States

Insight Clinical Trials LLC

Beachwood, Ohio, United States

Valley Medical Research

Centerville, Ohio, United States

Baylor Research Institute

Dallas, Texas, United States

Sante Clinical Research

Kerrville, Texas, United States

Be Well Clinical Studies

Round Rock, Texas, United States