The HEAD study is a pioneering research initiative focused on standardizing the interpretation of tau PET tracers, namely Flortaucipir, MK-6240, PI-2620, and RO948. These tracers are crucial for detecting tau pathology in Alzheimer's disease, and this study aims to harmonize their estimates to ensure consistency and accuracy across different research and clinical settings, with the goal to enhance the generalizability and impact of tau PET studies in AD.
HEAD brings together leading experts and institutions in the field of PET imaging and AD research. The collaborative effort involves 12 academic research sites, leveraging their extensive expertise and resources. This partnership ensures the study's rigorous design and execution, aiming to set new standards in tau PET imaging and contribute valuable knowledge to the scientific community
This longitudinal, multisite study will include 620 participants across nine specialized research centers. Participants, including cognitively unimpaired, mild cognitive impairment, and with dementia, undergo head-to-head tau PET scans with up to 4 tracers at baseline and 18-month follow-up. Additional assessments include amyloid PET, MRI, blood collection, and complete clinical assessment, ensuring a comprehensive evaluation of each participant.
The HEAD study has made significant strides in building the cohort and initiating data collection. We have currently enrolled over 600 participants across sites, ensuring robust and generalizable results. Data collection is ongoing, with participants currently completing baseline assessments and many completing follow-up evaluations. This rapid progress lays a strong foundation for achieving our aims.
The head-to-head tau PET tracer data collected in the HEAD study provides robust anchor values for tau PET harmonization. We employ innovative methodologies to calibrate tracers in order to generate an accurate universal tau-PET scale, named Uni𝜏 (Uni-tau), which we are continuously fine-tuning as we acquire data. An interactive tool is available below.
The HEAD study's outcomes are expected to have important implications for the Alzheimer's disease biomarker field. By guiding the selection of tau tracers for specific research hypotheses and clinical trials, the study will improve the interpretability and comparability of tau PET findings, facilitating the development of diagnostic and therapeutic strategies.
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