Alzheimer's Biomarkers Gain Prominence In Drug Development Guidance

US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.

Memory loss and brain aging due to dementia and alzheimer's disease as a medical icon of a group of color changing autumn fall trees shaped as a human head losing leaves on a white background.

Striving to advance Alzheimer's disease drug development, the US FDA has revised its draft guidance to give sponsors more leeway in trial designs.

The new draft guidance, released on Feb. 15, specifies categories of patients based on different stages of disease progression, and notes the clinical endpoints acceptable for these stages. The...

More from Approval Standards

More from Pathways & Standards