|
Activity Number:
|
505
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #305438 |
|
Title:
|
A Meta-Analytic Model for Alzheimer's Disease Incorporating Both Summary-Level and Patient-Level Data
|
|
Author(s):
|
James A. Rogers*+ and Bill Gillespie and Kaori Ito and Marc Gastonguay
|
|
Companies:
|
Metrum and Metrum and Pfizer Inc. and Metrum
|
|
Address:
|
2 Tunxis Road, Suite 112, Tariffville, CT, 06081,
|
|
Keywords:
|
meta-analysis ; longitudinal ; variance components ; Alzheimer's Disease ; Bayesian
|
|
Abstract:
|
The cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) is one of the conventional co-primary endpoints in clinical trials of Alzheimer's Disease (AD). The ability to realistically simulate longitudinal patient-level data for this endpoint is therefore helpful in designing AD clinical trials, in interpreting the results of those trials, and as a means of assessing the plausibility of various hypotheses about the disease. We present a novel approach to the simultaneous modeling of patient-level data (from proprietary sources) with summary data (from published sources), using Bayesian methodology. The incorporation of patient-level data in our meta-analyses enables the estimation of variance components that are relevant to trial design and sample size computations.
|