Publications by authors named "C Rubel"
Plasma biomarkers for Alzheimer's disease (AD) are increasingly being used to assist in making an etiological diagnosis for cognitively impaired (CI) individuals or to identify cognitively unimpaired (CU) individuals with AD pathology who may be eligible for prevention trials. However, a better understanding of the timing of plasma biomarker changes is needed to optimize their use in clinical and research settings. The aim of this study was to evaluate the timing of change of key AD plasma biomarkers (Aβ42/Aβ40, p-tau217, p-tau181, GFAP and NfL) from six different companies, along with established AD biomarkers, using AD progression timelines based on amyloid and tau PET.
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- The global incidence of dementia, particularly Alzheimer's disease (AD), is increasing, prompting the need for effective treatments like aducanumab, which targets amyloid beta involved in AD.
- Aducanumab was approved by the FDA in June 2021 for treating early AD through an accelerated approval process, supported by data from two global phase 3 studies, EMERGE and ENGAGE.
- In these studies, Japanese participants with a confirmed diagnosis of mild cognitive impairment or mild AD dementia were evaluated for the drug's efficacy, safety, and pharmacokinetics, with results aligning closely with the overall findings.
Changes in biomarker levels of Alzheimer's disease (AD) reflect underlying pathophysiological changes in the brain and can provide evidence of direct and downstream treatment effects linked to disease modification. Recent results from clinical trials of anti-amyloid β (Aβ) treatments have raised the question of how to best characterize the relationship between AD biomarkers and clinical endpoints. Consensus methodology for assessing such relationships is lacking, leading to inconsistent evaluation and reporting.
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