Guidance For Drugs To Target Early Alzheimer’s Notes Lack Of Metrics, Biomarkers

FDA’s new draft guidance on developing drugs for presymptomatic Alzheimer’s patients – the target population that researchers, drug makers and regulators agree is the best chance for affecting the course of the disease – reflects the general lack of tools available to measure or even identify progress.

Under a section on diagnostic criteria, the agency offers little advice on picking patients for a trial, instead stating that it can’t “formally endorse any specific diagnostic framework