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RECRUITINGPHASE3

[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)

NCT05641688•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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Only subjects who meet all of the following criteria will be eligible for enrollment into the study:
•1. Males and females aged 50 years and over
•2. Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limited to end-stage dementia, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease (COPD), or end-stage cancer)
•3. Written informed consent obtained from the subject and/or the subject's legally authorized representative (LAR), as applicable, to consent for study procedures and brain donation (consent consistent with the legal requirements of the State in which the subject dies)
•4. Can tolerate study procedures including lying down in PET scanner. The investigator will carefully assess each subject and use medical judgment to determine whether the subject can tolerate the imaging procedure

Exclusion Criteria

•Subjects will be excluded from the enrollment if they:
•1. Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
•2. Are known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment (e.g. lesions are typically \> 2 cm at their greatest extent and may include stroke, primary or metastatic neoplasm, other tumors or cystic lesions. Subjects with a history of major stroke or traumatic brain injury or other structural lesion as well as cases with a history of primary Central Nervous System (CNS) neoplasm or known metastatic cancer must be discussed with the study sponsor prior to enrollment)
•3. Have suspected encephalopathy due to alcoholism or end-stage liver disease
•4. Are known to have a Glomerular Filtration Rate below \< 15 mL/min
•5. Have received an investigational or approved therapy directly targeting amyloid or tau
•6. Are females of childbearing potential who are pregnant, lactating or breastfeeding, or who are not using adequate contraception
•7. Have implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI (in case an MRI is planned to be performed)

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

Key Dates

Start Date

December 1, 2022

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2027

Last Updated

January 7, 2026

Enrollment

200

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

[18F]PI-2620

DRUG

Contacts

Audrey Perrotin, PhD

CONTACT

+49 (0)30 461 1246 03 clinicaltrials@life-mi.com

Aleksandar Jovalekic, PhD

CONTACT

+49 (0)30 461 1246 03 clinicaltrials@life-mi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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[18F]PI-2620 Phase 3 Histopathological Study

Inclusion Criteria

Exclusion Criteria

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