AI Article Synopsis
- Alzheimer’s disease (AD) is a significant medical issue with no current approved treatments to cure or slow its progression.
- The paper discusses recent regulatory guidance on demonstrating disease modification and reviews methods applicable to clinical trials.
- The goal is to aid future clinical trials in proving disease-modifying effects in AD, with potential applicability to other neurodegenerative diseases.
Article Abstract
Alzheimer's disease (AD) has increasingly been recognized as a huge unmet medical need. Currently, there is no approved drug to cure, prevent, or even slow down the disease. It is imperative to develop disease-modifying treatments for AD to alter the underlying disease progression. This paper reviews the most up-to-date regulatory guidance on how to demonstrate disease modification and provides an overview of available methodologies and applications to clinical trials. The intent is to assist the field with future clinical trials designed to demonstrate disease-modifying effect in AD. The methodologies may be generalizable to broader neurodegenerative diseases.
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| http://dx.doi.org/10.1007/s43441-019-00068-4 | DOI Listing |
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