FDA: AD biomarkers won't yet support approval

FDA said the use of a biomarker as either a single primary endpoint or secondary endpoint measure will not yet support approval of a product to treat early Alzheimer's disease (AD). According to draft guidance on clinical trial design for products to treat early AD, an appropriate single primary endpoint would be the use of a composite scale that has been validated in early stage patients to assess cognition and function, such as the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score. For early stage AD, FDA said a time-to-dementia diagnosis is a "particularly appealing" primary efficacy measure. ...