Guidance for developing drugs to treat early Alzheimer’s disease should focus on factors such as cognitive changes and brain atrophy, according to comments submitted to the US Food and Drug Administration (FDA) on draft guidance addressing the subject.
In March, the FDA proposed an update to its 2018 draft guidance on developing drugs for early AD. It includes biomarkers and outcome measures that can be used to select clinical trial participants. Another major change in the guidance is that the agency said it will allow the use of endpoints based on cognitive assessments or surrogate endpoints. (RELATED: FDA updates early Alzheimer’s drug development guidance to add support for biomarkers, surrogate endpoints, Regulatory Focus 11 March 2024)…
