RightFit
RecruitingPhase 3

[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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and useful PET brain scans with [18F]PI-2620 are for finding buildup of a protein called tau. It compares scans taken during life with brain tests done after death. It is for adults age 50 or older, with or without Alzheimer's disease, who are expected to live one year or less.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 50 or older.
  • The study doctor expects you to live one year or less because of a terminal illness.
  • You or your legal representative give written consent for study procedures and brain donation after death, following state law.
  • The study doctor decides you can handle the study procedures, including lying down in a PET scanner.

Who can't join

  • You are getting aggressive treatment to keep you alive, such as chemotherapy. Chemotherapy meant to ease symptoms is allowed.
  • You have brain damage or an abnormal growth that could affect the scans or brain tests. Some histories of stroke, brain injury, or cancer must be discussed with the study sponsor before joining.
  • Doctors suspect brain problems caused by alcoholism or severe liver disease.
  • Your kidney filtering rate, called GFR, is below 15 mL/min.
  • You have received an approved or experimental treatment that directly targets amyloid or tau proteins.
  • You can become pregnant and are pregnant, breastfeeding, or not using adequate birth control.
  • If an MRI scan is planned, you have an implant or metal in your body that is not certified safe for MRI, or a history of fear of enclosed spaces during MRI.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (25)

AZ

CA

FL

MA

NC

NE

NH

NY

OH

TX