RecruitingPhase 3NCT05641688

[18F]PI-2620 Phase 3 Histopathological Study

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)

Sponsor

Life Molecular Imaging Ltd

Enrollment

200 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special brain scan (called a tau PET scan with [18F]PI-2620) to study how a protein called tau accumulates in the brains of people nearing the end of life. After death, brain tissue is donated so researchers can confirm what the scan detected. This helps improve the accuracy of tau PET scanning for diagnosing brain diseases. **You may be eligible if...** - You are 50 years or older - You have a terminal illness and a life expectancy of 1 year or less (such as end-stage dementia, heart failure, COPD, or cancer) - You are able to lie still in a PET scanner - You (or your legal representative) are willing to consent to the scan and to brain donation after death **You may NOT be eligible if...** - You are unable to lie down for the scan due to your medical condition - You or your legal representative declines brain donation - You do not meet the life expectancy criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05641688

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