[18F]PI-2620 Phase 3 Histopathological Study (NCT05641688)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Barrow Neurological Institute — Phoenix, Arizona
Age range: 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (25 Sites)
- Barrow Neurological Institute — Phoenix, Arizona
- Banner Sun Health Research Institute — Sun City, Arizona
- UC Los Angeles — Los Angeles, California
- Esperanza Clinical — Murrieta, California
- Sutter Health — San Francisco, California
- Galiz Research — Hialeah, Florida
- UF College of Medicine - Jacksonville — Jacksonville, Florida
- K2 Medical Research — Lady Lake, Florida
- K2 Medical Research — Maitland, Florida
- ClinCloud Research — Melbourne, Florida
- Miami Jewish Health Systems — Miami, Florida
- The Roskamp Institute — Sarasota, Florida
- Charter Research — Winter Park, Florida
- Alzheimer's Disease Center — Braintree, Massachusetts
- Headlands Research — Plymouth, Massachusetts
- Be Well Clinical Studies — Lincoln, Nebraska
- Darthmouth-Hitchcock Medical Center — Lebanon, New Hampshire
- Velocity Clinical Research — East Syracuse, New York
- Ichor Research — Syracuse, New York
- American Carolina Clinical Research LLC — Charlotte, North Carolina
- Insight Clinical Trials LLC — Beachwood, Ohio
- Valley Medical Research — Centerville, Ohio
- Baylor Research Institute — Dallas, Texas
- Sante Clinical Research — Kerrville, Texas
- Be Well Clinical Studies — Round Rock, Texas
📞 Contact the Study Coordinator
Phone: +49 (0)30 461 1246 03
Email: clinicaltrials@life-mi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.