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Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease
Sponsor: Tharick Pascoal
Summary
The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.
Official title: Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
822
Start Date
2022-03-02
Completion Date
2027-05-31
Last Updated
2025-10-29
Healthy Volunteers
Yes
Conditions
Interventions
18F-Flortaucipir radiopharmaceutical
Flortaucipir is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 10 millicuries of the radiopharmaceutical.
18F-MK-6240 radiopharmaceutical
MK-6240 is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 5 millicuries of the radiopharmaceutical.
Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)
The clinical sites will use either PiB, Florbetaben, Flutemetamol, or NAV-4694 as the amyloid-β PET radiopharmaceutical. The amyloid-β PET radiopharmaceutical binds to amyloid-β plaques. Participants will receive a bolus intravenous injection of approximately 15 millicuries of the PiB radiopharmaceutical. Participants will receive a bolus intravenous injection of approximately 8 millicuries of the Florbetaben or NAV-4694 radiopharmaceutical. Participants will receive a bolus intravenous injection of approximately 5 millicuries of the Flutemetamol radiopharmaceutical.
Locations (9)
Lawrence Berkeley National Laboratory
Berkeley, California, United States
University of California San Francisco
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
McGill University
Montreal, Quebec, Canada
Sant Pau Biomedical Research Institute
Barcelona, Spain, Spain