Tharick Pascoal
Tharick Pascoal
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.
Alzheimer Disease
18F-Flortaucipir radiopharmaceutical
18F-MK-6240 radiopharmaceutical
Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)
Phase 1
This is a longitudinal, multi-site, non-randomized study in which the participants will undergo Flortaucipir and MK-6240 PET scans at baseline and approximately at 18-month follow-up. At each time point, participants will also have an amyloid-β PET scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. The main objectives of this study are standardizing tau PET tracers' outcomes and comparing their performance. To accomplish our objectives, the investigators propose the following specific aims: In Aim 1, investigators will standardize tau PET processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize Braak staging assessments between tau tracers using cross-sectional data. In Aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau PET radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition. In Exploratory Aim 3, investigators will compare cross-sectional and longitudinal Flortaucipir and MK-6240 estimates with plasma phosphorylated tau concentrations. This study will produce a benchmark dataset to develop methods for tau PET quantification and harmonization.
Study Type : | Interventional |
Estimated Enrollment : | 620 participants |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers |
Actual Study Start Date : | August 2022 |
Estimated Primary Completion Date : | May 31, 2027 |
Estimated Study Completion Date : | May 31, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Individuals across the aging and Alzheimer's disease (AD) spectrum Approximately 620 individuals (40 young healthy, 280 cognitively unimpaired older, 200 mild cognitive impairment, and 100 Alzheimer's disease dementia) will be enrolled in the HEAD study. |
Drug: 18F-Flortaucipir radiopharmaceutical Drug: 18F-MK-6240 radiopharmaceutical Drug: Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694) |
Ages Eligible for Study: | 20 Years to 90 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Lawrence Berkeley National Laboratory
Berkeley, California, United States, 94720
Not yet recruiting
University of California San Francisco
San Francisco, California, United States, 94143
Not yet recruiting
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not yet recruiting
Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
Not yet recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Not yet recruiting
Brown University
Providence, Rhode Island, United States, 02912
Not yet recruiting
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Not yet recruiting
McGill University Research Centre for Studies in Aging
Montréal, Quebec, Canada, H4H1V3