FDA Draft Guidance for Industry: Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage of Disease

February 7, 2013
The U.S. Food and Drug Administration (FDA) issued this guidance to help companies developing medications for patients with early-stage Alzheimer’s disease before the onset of noticeable dementia symptoms. The FDA sought to clarify how researchers can identify and study patients with very early Alzheimer’s disease. For clinical trials, researchers can use biomarkers linked to Alzheimer’s disease, such as amyloid plaques in the brain to identify patients at higher risk of developing dementia and include them in studies. However, because clinical consensus is lacking on how change in biomarkers translates to change in . . .