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[18F]PI-2620 Phase 3 Histopathological Study
Sponsor: Life Molecular Imaging Ltd
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-12-01
Completion Date
2027-06
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
[18F]PI-2620
The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
Locations (25)
Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
UC Los Angeles
Los Angeles, California, United States
Esperanza Clinical
Murrieta, California, United States
Sutter Health
San Francisco, California, United States
Galiz Research
Hialeah, Florida, United States
UF College of Medicine - Jacksonville
Jacksonville, Florida, United States
K2 Medical Research
Lady Lake, Florida, United States
K2 Medical Research
Maitland, Florida, United States
ClinCloud Research
Melbourne, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
The Roskamp Institute
Sarasota, Florida, United States
Charter Research
Winter Park, Florida, United States
Alzheimer's Disease Center
Braintree, Massachusetts, United States
Headlands Research
Plymouth, Massachusetts, United States
Be Well Clinical Studies
Lincoln, Nebraska, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Velocity Clinical Research
East Syracuse, New York, United States
Ichor Research
Syracuse, New York, United States
American Carolina Clinical Research LLC
Charlotte, North Carolina, United States
Insight Clinical Trials LLC
Beachwood, Ohio, United States
Valley Medical Research
Centerville, Ohio, United States
Baylor Research Institute
Dallas, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States