JSM 2015 Preliminary Program

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Activity Number: 479
Type: Topic Contributed
Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #316880 View Presentation
Title: Finding Disease-Modifying Therapies for Alzheimer's Disease: A Bayesian Adaptive Development Platform
Author(s): Melanie Quintana* and Scott M. Berry and Mark Fitzgerald
Companies: Berry Consultants and Berry Consultants and Berry Consultants
Keywords: Bayesian ; Adaptive Clinical Trial ; Alzheimer's Disease ; Platform Trial ; Disease Progression
Abstract:

We describe the development of a Bayesian adaptive platform trial for determining the effectiveness of therapies for Alzheimer's Disease (AD). AD is the leading cause of dementia globally. Current approved therapies have only been shown to slow the worsening of symptoms but not alter the disease progression.

Our primary interest is in developing a platform trial with the infrastructure that enables simultaneous evaluation of multiple potential disease modifying therapies in individuals at risk for AD. The trial follows a two-stage design. The goal of the first stage is the demonstration of target biomarker modulation. The goal of the second stage is the demonstration of efficacy in terms of a cognitive benefit. Several innovative aspects of the design include: pooling of information from placebo patients across regimens, proposing to stop a regimen early for lack of biomarker efficacy, and proposing to advance the regimen to the cognitive endpoint stage due to positive benefit on the targeted biomarker.

Within our presentation we highlight the importance of clinical trial simulation in specifying key design parameters.


Authors who are presenting talks have a * after their name.

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