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Assessing tau deposition in Alzheimer's disease using PET imaging

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)

Phase 3 Interventional Life Molecular Imaging SA · NCT05641688

This study is testing a new type of brain scan to see if it can accurately detect tau buildup in people with Alzheimer's disease who have a serious illness and a limited life expectancy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages50 Years and up
SexAll
SponsorLife Molecular Imaging SA Industry-sponsored
Drugs / interventionschemotherapy
Locations25 sites (Phoenix, Arizona and 24 other locations)
Trial IDNCT05641688 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase 3 study evaluates the efficacy and safety of PET imaging with [18F]PI-2620 for detecting tau deposition in individuals with Alzheimer's disease compared to post-mortem histopathology. The study aims to enroll subjects aged 50 and over who have a terminal medical condition and a projected life expectancy of one year or less. Participants will undergo PET imaging to assess tau levels, with the goal of correlating these findings with brain autopsy results after death.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 50 years and older with a terminal medical condition and a projected life expectancy of one year or less.

Not a fit: Patients who do not have a terminal medical condition or are younger than 50 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of Alzheimer's disease diagnosis and improve understanding of tau pathology.

How similar studies have performed: Other studies using PET imaging for tau detection have shown promise, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Phoenix, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.