Assessing tau deposition in Alzheimer's disease using PET imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• Banner Sun Health Research Institute
  Sun City, Arizona, United States Recruiting
• UC Los Angeles
  Los Angeles, California, United States Recruiting
• Esperanza Clinical
  Murrieta, California, United States Recruiting
• Sutter Health
  San Francisco, California, United States Recruiting
• Galiz Research
  Hialeah, Florida, United States Recruiting

Study contacts

• Principal investigator: Alireza Atri, MD, PhD — Banner Health
• Study coordinator: Audrey Perrotin, PhD
• Email: clinicaltrials@lantheus.com
• Phone: +49 (0)30 461 1246 03

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

• Cervical lymphatic surgery to see if it helps people with mild Alzheimer’s

  We’re testing a surgical approach in people with mild Alzheimer’s to see if creating alternative neck lymph drainage routes can affect brain biomarkers and daily function.

  Recruiting at 2 sites Maliszewski Daniel · Gdansk and 1 other locations · NCT07857759

• Transcranial random noise stimulation for behavioral and psychological symptoms in Alzheimer's disease

  This trial tests whether high-frequency transcranial random noise stimulation can help people with early Alzheimer's disease who have BPSD, compared to a sham treatment.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT07827196

• Testing LY4405094 in healthy people and people with Alzheimer’s disease

  This study tests LY4405094 to see if it is safe and how it behaves in the body, including how it reaches the brain fluid in healthy participants and how it affects a brain protein in people with Alzheimer's disease.

  Recruiting Phase 1 Eli Lilly and Company · Anaheim, California and 17 other locations · NCT07787182

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.