Clinical Outcome Assessments in Early-stage Alzheimer's Disease Clinical Trials, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will give an overview of clinical staging as defined by the NIA-AA Research Framework and FDA early AD draft guidance and discuss current endpoints and key challenges to data quality that can be mitigated by the use of eCOA, training and monitoring. Attendees will learn how to deliver training and certification programs and risk-based central monitoring strategies to ensure endpoint data quality.
TORONTO, Aug. 19, 2021 /PRNewswire-PRWeb/ -- 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.
Register for 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.
Join expert speakers from Cogstate, Chris Edgar, PhD, Chief Science Officer and Edward Bartolic, PhD, Senior Director, Clinical Science, as well as Rinah Yamamoto, PhD, Principal Scientist, Clinical Ink, in a live webinar on Friday, September 10, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Clinical Outcome Assessments in Early-stage Alzheimer's Disease Clinical Trials.
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