Roy Yaari, Karen C. Holdridge, Melissa Williamson, Alette M. Wessels, Sergey Shcherbinin, Vikas Kotari, Eric M. Reiman, Pierre N. Tariot, Robert Alexander, Jessica B. Langbaum, John R. Sims
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A sub-study will evaluate longitudinal changes in amyloid and tau positron emission tomography (PET).</p>\n </section>\n \n <section>\n \n <h3> RESULTS</h3>\n \n <p>Participants 55–80 years of age were screened (<i>N</i> = 63,124). Plasma p-tau217-eligible participants were enrolled (<i>N</i> = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (<i>n</i> = 1202) and 0.5 (<i>n</i> = 664). Plasma p-tau217 eligibility increased with age, differing across races and ethnicities. Mean baseline amyloid levels were 63.2 (CDR-GS: 0) and 70.7 Centiloids (CDR-GS: 0.5). 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Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3
INTRODUCTION
TRAILBLAZER-ALZ 3 is investigating donanemab in preclinical Alzheimer's disease (AD).
METHODS
This double-blind, placebo-controlled trial used a plasma phosphorylated tau-217 (p-tau217) assay to detect AD pathology for eligibility and a decentralized design to enhance screening and enrollment. After nine monthly infusions, clinical assessments continue every 6 months with a time-to-event primary outcome. A sub-study will evaluate longitudinal changes in amyloid and tau positron emission tomography (PET).
RESULTS
Participants 55–80 years of age were screened (N = 63,124). Plasma p-tau217-eligible participants were enrolled (N = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (n = 1202) and 0.5 (n = 664). Plasma p-tau217 eligibility increased with age, differing across races and ethnicities. Mean baseline amyloid levels were 63.2 (CDR-GS: 0) and 70.7 Centiloids (CDR-GS: 0.5). Elevated global tau signal (standardized uptake value ratio ≥1.10) was observed in 15.1% and 26.3% of CDR-GS 0 and 0.5 subgroups, respectively.
DISCUSSION
Utilizing a unique decentralized design, the trial showed baseline data consistent with preclinical AD.
期刊介绍：
Alzheimer's & Dementia is a peer-reviewed journal that aims to bridge knowledge gaps in dementia research by covering the entire spectrum, from basic science to clinical trials to social and behavioral investigations. It provides a platform for rapid communication of new findings and ideas, optimal translation of research into practical applications, increasing knowledge across diverse disciplines for early detection, diagnosis, and intervention, and identifying promising new research directions. In July 2008, Alzheimer's & Dementia was accepted for indexing by MEDLINE, recognizing its scientific merit and contribution to Alzheimer's research.
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