Studies of investigational drugs targeting the dementia stage of Alzheimer’s disease (AD) have used a co-primary approach to assess cognitive and functional (or global) measures. This approach ensured both a clinically meaningful effect by a demonstration of benefit on the functional measure and that the observed functional benefit was accompanied by an effect on the core symptoms of the disease as measured by the cognitive assessment.
As the scientific understanding of AD has evolved, enrollment of patients with AD at earlier stages where there may be no functional impairment or even no detectable clinical abnormality has become possible, as it is desirable to delay or halt disease at the earliest opportunity. Such clinical trials necessitate the use of different clinical assessments to select trial participants and/or novel endpoints to demonstrate treatment benefit, including single primary endpoints based on cognitive assessment alone.
Watch this webinar to hear three experts describe the identification and selection of clinical outcome assessments and endpoints for early (clinical stages 1 to 3) clinical trials in AD and outline strategies for optimizing their implementation through enhanced eCOA and innovative data quality programs.
Chris Edgar, PhD
Chief Science Officer, Cogstate
Edward Bartolic, PhD
Senior Director, Clinical Science, Cogstate
Rinah Yamamoto, PhD
Principal Scientist, Clinical Ink