The American journal of managed care
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The burden of Alzheimer disease (AD) on the US healthcare system is substantial and increasing. AD progresses along a continuum from preclinical disease characterized by normal cognition and abnormal brain biomarkers to mild cognitive impairment and then clinically apparent dementia. Diagnosis early in the AD continuum has benefits for patients and caregivers and appears cost-effective, but often, the clinical diagnosis of AD may be delayed. ⋯ Within the past few years, significant achievements that will advance clinical trials in early AD include the Research Framework to define and stage the AD continuum, FDA guidance on study design in early AD, and development of scales to measure cognition that are suitable for early AD. In October 2019, the AD community was re-invigorated by unexpected news that a Biologics License Application will be submitted for aducanumab to treat AD. This article explores the current state of biomarker-driven drug development across the AD continuum and reviews investigational drugs in phase 2/3 clinical development for AD.
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In the coronavirus disease 2019 (COVID-19) era, clinical registries and innovative virtual care delivery tools should be leveraged to engage populations in effective chronic disease management.
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To mark the 25th anniversary of the journal, each issue in 2020 will include an interview with a health care thought leader. The August issue features a conversation with Mandy K. Cohen, MD, MPH, secretary of the North Carolina Department of Health and Human Services.