Improving Early Decisionmaking for Alzheimer's Disease

• Activity Number: 305
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Robin Mogg*+ and Devan V. Mehrotra and Arthur Simen
• Companies: Merck and Merck and Merck
• Keywords: Alzheimer's disease ; Proof of concept study ; Platform development

Abstract

Assessing new symptomatic therapy drugs for potential efficacy in Alzheimer's disease (AD) is costly and difficult. Dose selection is poorly predicted by the pharmacodynamics of Phase 1 studies, and proof of concept is typically assessed by an improvement in cognition using the traditional ADAS-cog endpoint which requires large Phase 2A sample sizes (>100 per group). As such, there is an urgent need for novel clinical trial methodology to enable more cost effective strategies for early decision making. In this talk, we discuss a potential platform to test symptomatic therapies in mild AD patients that is cheaper and potentially faster. The planned platform utilizes validated tests of cognition that are highly focused on relevant cognitive domains and frequently administered to enable signal detection in smaller sample sizes with sufficient precision to make efficient early Go/No-go decisions. We highlight the potential benefits of the new platform through simulation.