[18F]PI-2620 Phase 3 Histopathological Study

Recruiting now · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT05641688

Run by

Lantheus Biosciences Ltd.

People needed

200

Starts

2022-12-01

Expected to finish

2027-06-01

Last updated by the study team

2026-05-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Only subjects who meet all of the following criteria will be eligible for enrollment into the study:
• Males and females aged 50 years and over
• 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)
• 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)
• 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

You may not qualify if…

• Subjects will be excluded from the enrollment if they:
• Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
• 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)
• Have suspected encephalopathy due to alcoholism or end-stage liver disease
• Are known to have a Glomerular Filtration Rate below < 15 mL/min
• Have received an investigational or approved therapy directly targeting amyloid or tau
• Are females of childbearing potential who are pregnant, lactating or breastfeeding, or who are not using adequate contraception
• 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 is running

• Be Well Clinical Studies — Round Rock, Texas, United States (enrolling)
• Banner Sun Health Research Institute — Sun City, Arizona, United States (enrolling)
• UC Los Angeles — Los Angeles, California, United States (enrolling)
• Esperanza Clinical — Murrieta, California, United States (enrolling)
• Sutter Health — San Francisco, California, United States (enrolling)
• Galiz Research — Hialeah, Florida, United States (enrolling)
• Insight Clinical Trials LLC — Beachwood, Ohio, United States (enrolling)
• Valley Medical Research — Centerville, Ohio, United States (enrolling)
• Baylor Research Institute — Dallas, Texas, United States (enrolling)
• Sante Clinical Research — Kerrville, Texas, United States (enrolling)
• Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
• K2 Medical Research — Lady Lake, Florida, United States (enrolling)
• K2 Medical Research — Maitland, Florida, United States (enrolling)
• ClinCloud Research — Melbourne, Florida, United States (enrolling)
• Miami Jewish Health Systems — Miami, Florida, United States (enrolling)
• Charter Research — Winter Park, Florida, United States (enrolling)
• Alzheimer's Disease Center — Braintree, Massachusetts, United States (enrolling)
• Darthmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Velocity Clinical Research — East Syracuse, New York, United States (enrolling)
• Ichor Research — Syracuse, New York, United States (enrolling)
• UF College of Medicine - Jacksonville — Jacksonville, Florida, United States
• The Roskamp Institute — Sarasota, Florida, United States
• Be Well Clinical Studies — Lincoln, Nebraska, United States
• American Carolina Clinical Research LLC — Charlotte, North Carolina, United States
• Headlands Research — Plymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.