FDA Draft Guidance on Early-Stage Alzheimer’s Covers Endpoint, Patient Selection

FDA draft guidance on early-stage Alzheimer’s drugs offers tips on endpoint selection, patient selection and showing disease modification. The guidance applies to drugs that treat patients before the onset of overt dementia. Those closest to developing overt dementia may have mild but noticeable impairments in daily functioning, and it is important to show an effect on those impairments in addition to showing an improvement in cognition, the guidance states.
Drug Industry Daily